November 15, 2008Safety concerns drive call for drug studies that involve pregnant - Baltimore Sun Safety concerns drive call for drug studies that involve pregnant - Baltimore Sun
Very few drugs are approved for use during pregnancy. Yet millions of pregnant women each year take prescribed medication to treat high blood pressure or depression or cancer, without meaningful data on whether the drugs are safe for them or their Source: www.baltimoresun.com FDA to detain food shipments from China - Atlanta Journal Constitution Federal health officials on Thursday ordered dozens of imported foods from China held at the border as possible health risks. Most are ethnic treats, including snacks, drinks and chocolates. It’s unusual for the Food and Drug Administration to put Source: www.ajc.com Elderly brace for more costly drug coverage in ‘09 - Atlanta Journal Constitution Robert Clark describes himself as a bit of a tight wad. So he’s a little perplexed about the news from his Medicare drug plan. His monthly premium will rise from about $25 a month to about $41 a month next year. And his wife, June, will face the Source: www.ajc.com Drug Slows Down Lung Cancer, Study Shows - eNews 2.0 Tarceva, a new drug released by OSI Pharmaceuticals Inc. and its partners from Melville, may do miracles for the ones who have lung cancer. The doctors announced on Friday that Tarceva could really help in slowing down the process of lung cancer if Source: www.enews20.com FDA ignored evidence of a threat to nation's babies and young children - Eureka Times-Standard If you picked the Food and Drug Administration (FDA), be prepared for disappointment, because the agency is under fire for ignoring scientific evidence and using flawed methods when it determined that bisphenol A (BPA), a chemical used in baby Source: www.times-standard.com A drug company on trial - Minneapolis Star Tribune For years, pharmaceutical companies have asked Congress to pass a law protecting them from liability lawsuits for drugs that have been approved by the U.S. Food and Drug Administration. Members of Congress, knowing only too well the fallibility of Source: www.startribune.com FDA reports 'serious' side-effects from wrinkle-filling drugs - Los Angeles Times FDA reports 'serious' side-effects from wrinkle-filling drugs - Los Angeles Times
Some people who received injections of dermal wrinkle fillers suffered "serious and unexpected" side effects, such as the loss of control facial muscles, disfigurement and rare life-threatening allergic reactions, U.S. regulators said Friday. There Source: www.latimes.com FDA Issues Alert over Chinese Imports - Eflux Media The US Food and Drug Administration on Thursday issued an alert warning Americans not to consume any products with milk ingredients imported from China because of concern about such products being contaminated with the toxic chemical melamine. In Source: www.efluxmedia.com FDA panel sees small benefit to Alpharma pain pill - WTOP Radio GAITHERSBURG, Md. (AP) - Government health advisers said Friday an experimental morphine pill from Alpharma could discourage some patients from abusing the powerful narcotic but provides only a small advantage over existing drugs. Alpharma has asked Source: www.wtopnews.com FDA to detain food shipments from China - Atlanta Journal Constitution Federal health officials on Thursday ordered dozens of imported foods from China held at the border as possible health risks. Most are ethnic treats, including snacks, drinks and chocolates. It’s unusual for the Food and Drug Administration to put Source: www.ajc.com US imposes melamine controls on Chinese food imports - AsiaNews.IT Asia News CHINA – UNITED STATES US imposes melamine controls on Chinese food imports china united states melamine food and drugs administration rules inspections kidney problems food safety FDA is set to conduct closer inspections of many imported Source: www.asianews.it A drug company on trial - Minneapolis Star Tribune For years, pharmaceutical companies have asked Congress to pass a law protecting them from liability lawsuits for drugs that have been approved by the U.S. Food and Drug Administration. Members of Congress, knowing only too well the fallibility of Source: www.startribune.com Applied Biosystems and Asuragen Collaborate with the Critical Path - PR Inside Applied Biosystems and Asuragen Collaborate with the Critical Path - PR Inside
www.appliedbiosystems.com - Applied Biosystems Mark Springer, 650-638-6113 (Media) mark.springer@appliedbiosystems.com William Craumer, 650-638-6382 (Investors) william.craumer@appliedbiosystems.com Drug toxicity accounts for billions of lost dollars Source: www.pr-inside.com Anticancer drug Tarceva slows lung cancer - new study - Food Consumer OSI Pharmaceuticals Inc. and its partners said Friday the results of a new study showed the drug Tarceva or erlotinib effectively slows the progression of lung cancer when given immediately after chemotherapy. The study called Saturn will be released Source: foodconsumer.org FDA to detain food shipments from China - Atlanta Journal Constitution Federal health officials on Thursday ordered dozens of imported foods from China held at the border as possible health risks. Most are ethnic treats, including snacks, drinks and chocolates. It’s unusual for the Food and Drug Administration to put Source: www.ajc.com FDA Issues Alert over Chinese Imports - Eflux Media FDA Issues Alert over Chinese Imports - Eflux Media
The US Food and Drug Administration on Thursday issued an alert warning Americans not to consume any products with milk ingredients imported from China because of concern about such products being contaminated with the toxic chemical melamine. In Source: www.efluxmedia.com FDA panel sees small benefit to Alpharma pain pill - San Francisco Gate Alpharma has asked the Food and Drug Administration to approve its drug Embeda as a tamper-resistant medication for patients with moderate to severe chronic pain. The pills are formulated so that the euphoric effects of morphine are blocked when a Source: www.sfgate.com Biodel Reports Protective Effects of VIAject(TM) Insulin on - Earthtimes DANBURY, Conn. - (Business Wire) Biodel Inc. (Nasdaq: BIOD) today reported positive effects of VIAject ™ insulin on microvascular function in patients with Type 2 diabetes which were superior to results seen with regular human insulin and insulin Source: www.earthtimes.org FDA reports 'serious' side-effects from wrinkle-filling drugs - Los Angeles Times Some people who received injections of dermal wrinkle fillers suffered "serious and unexpected" side effects, such as the loss of control facial muscles, disfigurement and rare life-threatening allergic reactions, U.S. regulators said Friday. There Source: www.latimes.com U.S closes its doors to Chinese dairy imports - The Money Times New York, November 15: Contaminated Chinese imports including melamine-laden milk has forced U.S Food and Drug Administration (FDA) to crack down on dairy imports from the country in order to safeguard public health. Melamine is a chemical substance Source: www.themoneytimes.com It's a question of trust - Chicago Tribune Han Wei, director of Chinese egg producer Hanwei Eggs, said he didn't know how melamine—a plastic additive not meant for human consumption—made its way into his company's eggs. His firm, he told CNN, never purchased melamine. He apologized Source: www.chicagotribune.com FDA: Dermal Fillers for Wrinkles Linked to Serious Side Effects - Top News India According to the Food and Drug Administration, Plans are underway to review the labeling of certain wrinkle-filler products, also known as dermal fillers, as some people suffered ``serious and unexpected'' side effects such as the inability to Source: www.topnews.in Propafenone HCl Tablets (150 mg, 225 mg, 300 mg), Isosorbide Mononitrate Extended Release Tablets (30 mg and 60 mg), Morphine Sulfate Extended Release Tablets (15 mg), Morphine Sulfate Immediate Release Tablets (15 mg and 30 mg), Dextroamphetamine Sulfate Tablets (10 mg) Propafenone HCl Tablets (150 mg, 225 mg, 300 mg), Isosorbide Mononitrate Extended Release Tablets (30 mg and 60 mg), Morphine Sulfate Extended Release Tablets (15 mg), Morphine Sulfate Immediate Release Tablets (15 mg and 30 mg), Dextroamphetamine Sulfate Tablets (10 mg)
Generic products recalled because of the potential for oversized tablets that could cause serious or life-threatening consequences. September 2008 Safety-Related Labeling Changes Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. Raptiva (efalizumab) Risk of life-threatening infections associated with Raptiva use. Update on Early Communication: Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D); Etidronate (Didronel); Ibandronate (Boniva); Pamidronate (Aredia); Risedronate (Actonel, Actonel W/Calcium); Tiludronate (Skelid); Zoledronic acid (Reclast, Zometa) Early Communication about the FDA's review of safety data showed no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Web site for additional information Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Related information section for updated Letter from Mallinckrodt Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch See Related information section Drug Shortages: Current Drug Shortages; Argatroban Injection See Related information section Vaccines Stand Ready for Flu Season Vaccines Stand Ready for Flu Season
FDA has approved six vaccines for the 2008-2009 flu season. Recalls and Safety Alerts: Serious Hypersensitivity Reactions with Abacavir (Ziagen) FDA is alerting healthcare professionals that certain patients are more likely to experience serious and potentially fatal hypersensitivity reactions when treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen an... Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) Recalls and Safety Alerts: Updated Warning on Byetta In October 2007, FDA warned healthcare professionals about reports of acute pancreatitis in patients taking the antidiabetic drug Byetta (exenatide). Since then, FDA has received reports of six cases of hemorrhagic or necrotizing pancreatitis in pat... Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva. November 14, 2008China recalls defective IV needles - PR Inside China recalls defective IV needles - PR Inside
BEIJING (AP) - China is recalling a defective batch of intravenous needles after a one easily broke and became embedded in a baby's scalp, the latest in a string of product safety problems for the country. The incident occurred in October at a Source: www.pr-inside.com Melamine-tainted food to be burned - Nation - Thailand The Public Health Ministry will tomorrow burn food products that were found with melamine in excess of permissible standards, the Food and Drug Administration (FDA) secretary-general said yesterday. Pipat Yingseree said the burning of 13,085 boxes of Source: www.nationmultimedia.com Home and garden news and notes - Norwalk Hour Both you and your brews can chill in your man cave with the Redhook Toolbox Fridge from Redhook Ale Brewery. The compact refrigerator, designed to look like a rolling tool cabinet, offers just the right testosterone touch for a basement, garage or Source: www.thehour.com Identifying Women With HPV Improves Early Intervention - eMaxHealth.com Merck's HPV Vaccine Gardasil Shows Potential For Men Cervical Cancer Vaccine To Be Extended MRI Technique May Identify Cervical Cancer Early One in Four Teenage Girls Receives HPV Vaccine New HPV Vaccine Requirement Needed As testing for high-risk Source: www.emaxhealth.com US seizes Chinese dairy food - China Economic Net The US Food and Drug Administration (FDA) on Thursday said it will impound all food products with milk ingredients from China if they are found to contain melamine. An alert notice on the agency's website said Chinese products that contain milk or Source: en.ce.cn China closes herbal drug firm linked to deaths - Reuters UK BEIJING (Reuters) - China, battling to restore trust in its products amid a tainted milk scandal, has closed a local pharmaceutical company whose herbal injections have been linked to the deaths of three people. China last month expanded a product Source: uk.reuters.com Spending on drug ads down this year, study says - Myrtle Beach Online TRENTON, N.J. -- Consumer ads for medication have declined this year - the second annual drop after years of strong growth - as drugmakers spend less on TV and other ads for newly approved drugs. That, in turn, is because the latest drugs have been Source: www.myrtlebeachonline.com Tarceva maker: Study shows drug slows lung cancer - Newsday OSI Pharmaceuticals Inc. of Melville and its partners in an anti-lung cancer drug said Friday that results of a new study they conducted showed the medication, Tarceva, helped slow the progress of the disease when given immediately after chemotherapy Source: www.newsday.com Gilead says Teva asks for generic Truvada approval - Boston Globe FOSTER CITY, Calif.— Teva Pharmaceutical Industries Inc. has asked the Food and Drug Administration to approve its generic version of Gilead Sciences Inc.'s HIV drug Truvada, Gilead said Friday. Gilead said Israel-based Teva has submitted an Source: www.boston.com Anticancer drug Tarceva slows lung cancer - new study - Food Consumer OSI Pharmaceuticals Inc. and its partners said Friday the results of a new study showed the drug Tarceva or erlotinib effectively slows the progression of lung cancer when given immediately after chemotherapy. The study called Saturn will be released Source: foodconsumer.org Elderly Brace For Jump In Drug Costs - CBS 2 KCAL 9 Elderly Brace For Jump In Drug Costs - CBS 2 KCAL 9
(AP) Robert Clark describes himself as a bit of a tight wad. So he's a little perplexed about the news from his Medicare drug plan. His monthly premium will rise from about $25 a month to about $41 a month next year. And his wife, June, will face the Source: cbs2.com address to receive our - Down Town News Combine those high school assemblies where police officers tell horror stories about the devastating effects of narcotics with those classic public service announcements such as the "This is your brain on drugs" commercial with an egg frying in a pan Source: www.downtownnews.com Gilead Sciences Announces Notification of ANDA Filing for Truvada - PR Inside www.gilead.com - Gilead Sciences, Inc. (Nasdaq:GILD) today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Source: www.pr-inside.com Gilead mulls patent fight with Teva - Birmingham Business Journal Gilead Sciences Inc. will study an application made by rival Teva Pharmaceuticals to the FDA for a generic version of the HIV drug Truvada, and decide within 45 days whether to file a patent suit. Foster City-based Gilead (NASDAQ: GILD) markets Source: www.bizjournals.com PCMA: ‘ Change to Win ’ Agenda Will Increase Prescription Drug - Businesswire.com WASHINGTON--( BUSINESS WIRE )--The Pharmaceutical Care Management Association (PCMA) released the following statement today in response to the agenda being advocated by the group “ Change to Win ” : "Pharmacy benefit managers (PBMs) typically Source: www.businesswire.com Consumer drug ads down this year, report says - WTOP Radio TRENTON, N.J. (AP) - Consumer ads for medication have declined this year _ the second annual drop after years of strong growth _ as drugmakers spend less on TV and other ads for newly approved drugs. That, in turn, is because the latest drugs have Source: www.wtopnews.com FDA panel sees small benefit to Alpharma pain pill - San Francisco Gate Alpharma has asked the Food and Drug Administration to approve its drug Embeda as a tamper-resistant medication for patients with moderate to severe chronic pain. The pills are formulated so that the euphoric effects of morphine are blocked when a Source: www.sfgate.com FDA panel sees small benefit to Alpharma's abuse-resistant morphine - Baltimore Sun FDA panel sees small benefit to Alpharma's abuse-resistant morphine - Baltimore Sun
GAITHERSBURG, Md. (AP) _ Government health advisers said Friday an experimental morphine pill from Alpharma could discourage some patients from abusing the powerful narcotic but provides only a small advantage over existing drugs. Alpharma has asked Source: www.baltimoresun.com Tiotropium (marketed as Spiriva HandiHaler) Tiotropium (marketed as Spiriva HandiHaler)
UPDATE - Preliminary results of the UPLIFT Trial shows no increased risk of stroke with tiotropium bromide. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Bottled Water Everywhere: Keeping it Safe Americans drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe. Improper Use of Decorative Contacts May Haunt You Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision FDA Requires Stronger Fungal Infection Warning for TNF Blockers FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling. Vaccines Stand Ready for Flu Season FDA has approved six vaccines for the 2008-2009 flu season. Use Caution With Ayurvedic Products Use Caution With Ayurvedic Products
The presence of heavy metals in some Ayurvedic products makes them potentially harmful. FDA Warns Bayer About Two Unapproved Aspirin Products FDA has sent warning letters to Bayer HealthCare regarding two over-the-counter products that combine aspirin with a dietary supplement into a single pill. Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, FDA issued a Health Information Advisory on September 12, 2008. Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Web site for additional information Mexican Vanilla With Coumarin: No Bargain Beware of Mexican vanilla that contains coumarin, a toxic substance banned in the United States. FDA Approves Toviaz, a New Drug to Treat Overactive Bladder The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. Keeping Watch Over Direct-to-Consumer Ads FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate. Is It Really FDA Approved? Some marketers say their products are "FDA approved", but how can you know for sure? FDA orders certain China foods held - Arizona Daily Star FDA orders certain China foods held - Arizona Daily Star
WASHINGTON — Federal health officials on Thursday ordered dozens of imported foods from China held at the border as possible health risks. Most are ethnic treats, including snacks, drinks and chocolates. It's unusual for the Food and Drug Source: www.azstarnet.com U.S. Restricts China Milk Products - Wall Street Journal WASHINGTON -- The Food and Drug Administration has restricted the entry of all food products from China containing milk after inspectors found evidence of melamine contamination, which has sickened tens of thousands of Chinese infants and caused at Source: online.wsj.com PCMA: New Commonwealth Fund Survey Shows Patients Are Skipping Care - PR Inside pcmanet.org/ - A new survey from the Commonwealth Fund comparing patients in the United States to those in seven other countries finds more than half of chronically ill patients did not get recommended care, fill prescriptions, or see a doctor when Source: www.pr-inside.com UPDATE 2-AMAG says FDA accepts anemia drug response; shares soar - Reuters BANGALORE, Nov 13 (Reuters) - AMAG Pharmaceuticals Inc (AMAG.O: Quote , Profile , Research , Stock Buzz ) said U.S. health regulators accepted the complete response for its experimental anemia drug, ferumoxytol, sending its shares soaring 86 percent Source: www.reuters.com Register for FREE - Wall Street Journal Please register to gain free access to WSJ tools. An account already exists for the email address entered. Two months after China’s melamine-tainted milk scandal first made headlines around the world, the U.S. Food and Drug Administration said it Source: blogs.wsj.com FDA to detain food from China as health precaution - Austin American-Statesman WASHINGTON — Federal health officials on Thursday ordered dozens of imported foods from China held at the border for possible health risks. Most are ethnic treats, including snacks, drinks and chocolates. It's unusual for the Food and Drug Source: www.statesman.com November 13, 2008Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes (October 22) Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes (October 22)
This product is distributed through retailers in the Greater New Orleans area including the Northshore from October 8, 2008 to October 17, 2008. The product is individually wrapped in clear plastic wrap bearing the label: "STUFFED ARTICHOKE, Net Wt. 15 oz., NONNA'S REAL ITALIANA CUCCINE". General Mills Issues Voluntary Class One Recall Involving One Day's Production of Progresso Hearty Tomato Soup (October 31) General Mills is voluntarily recalling a single day's production of Progresso Hearty Tomato soup because of a product labeling issue. Product produced on this date may have been mislabeled, and may contain allergens not listed on the ingredient label, specifically egg, milk, and soy. Recalls and Safety Alerts: Increased Risk of Death in Elderly Patients Taking Conventional Antipsychotics for Dementia FDA is requiring that "conventional" antipsychotic drugs carry a boxed warning stating that these drugs increase the risk of death when they are used to treat dementia-related psychosis in elderly patients. This category includes such drugs as Haldo... Recalls and Safety Alerts: Serious Hypersensitivity Reactions with Abacavir (Ziagen) FDA is alerting healthcare professionals that certain patients are more likely to experience serious and potentially fatal hypersensitivity reactions when treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen an... Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap. Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24) Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments (November 7) Johnson and Johnson -- Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella. FDA to detain food shipments from China - Boston Globe FDA to detain food shipments from China - Boston Globe
WASHINGTON— Federal health officials Thursday slapped a sweeping detention order on dozens of imported foods from China, from snacks and drinks to chocolates and candies. It's unusual for the Food and Drug Administration to put such a broad hold on Source: www.boston.com UPDATE 2-AMAG says FDA accepts anemia drug response; shares soar - Reuters BANGALORE, Nov 13 (Reuters) - AMAG Pharmaceuticals Inc (AMAG.O: Quote , Profile , Research , Stock Buzz ) said U.S. health regulators accepted the complete response for its experimental anemia drug, ferumoxytol, sending its shares soaring 86 percent Source: www.reuters.com FDA to detain some food shipments from China - San Diego Union-Tribune FDA to detain some food shipments from China - San Diego Union-Tribune
The Food and Drug Administration says foods made with milk will be held at ports of entry, as a precaution, until independent tests show they are free of the industrial chemical melamine. The order, which also applies to pet foods, was posted on the Source: www.signonsandiego.com Amag Soars as FDA Plans Quick Drug Review - Street.Com Shares of Amag Pharmaceuticals ( AMAG Quote - Cramer on AMAG - Stock Picks ) rocketed on Thursday after the company said the Food and Drug Administration will give a speedy review to its latest submission for an iron-replacement therapy. Shares of Source: www.thestreet.com AMAG jumps as FDA accepts anemia drug response - MSN MoneyCentral LEXINGTON, Mass. (AP) - AMAG Pharmaceuticals Inc. said Thursday the Food and Drug Administration has accepted additional data filed on its anemia drug candidate ferumoxytol, and should making a ruling on the drug's approval by Dec. 30. The news sent Source: news.moneycentral.msn.com FDA Detains Dozens of Chinese Food Imports Over Health Concerns - FOX News U.S. government health officials Thursday slapped a sweeping detention order on dozens of imported foods from China, from snacks and drinks to chocolates and candies. It is unusual for the Food and Drug Administration to put such a broad hold on Source: www.foxnews.com REFILE-UPDATE 1-AMAG says FDA accepts anemia drug response - Reuters Nov 13 (Reuters) - AMAG Pharmaceuticals Inc (AMAG.O: Quote , Profile , Research , Stock Buzz ) said U.S. health regulators accepted the complete response for its experimental anemia drug, sending its shares soaring 72 percent in pre-market trade. In Source: www.reuters.com Is It Really FDA Approved? Is It Really FDA Approved?
Some marketers say their products are "FDA approved", but how can you know for sure? Recalls and Safety Alerts: Importance of Influenza Vaccination for Health Care Personnel As the flu season approaches, FDA is urging healthcare facilities to ensure that influenza vaccination programs are available for their personnel. Vaccinating healthcare workers will decrease the likelihood that they will contract influenza, and als... Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) See Web site for additional information. Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, FDA issued a Health Information Advisory on September 12, 2008. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Recalls and Melamine Contamination FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Related information section for updated Letter from Mallinckrodt FDA Requires Stronger Fungal Infection Warning for TNF Blockers FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling. Food Safety Tips for Healthy Holidays FDA gives consumers practical food safety tips to help prevent foodborne illness. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies
Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap. Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22) Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product. November 12, 2008UPDATE 2-FDA: data shows no clear heart risk from bone drugs - Reuters UPDATE 2-FDA: data shows no clear heart risk from bone drugs - Reuters
WASHINGTON, Nov 12 (Reuters) - Clinical trial data from four drugmakers shows no overall risk of heart problems in patients taking certain drugs to treat osteoporosis, the U.S. Food and Drug Administration said on Wednesday. The agency reviewed Source: www.reuters.com ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15) ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15)
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side. FDA Approves Toviaz, a New Drug to Treat Overactive Bladder The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. FDA Warns Public of Extortion Scam by FDA Impersonators The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. New from FDA: FDA?s Drug Safety Newsletter Now Available Every year, FDA receives more than 400,000 reports of adverse events associated with the use of drugs marketed in the U.S. FDA continually reviews these reports to identify signals of potential drug risks. The Drug Safety Newsletter is one way ... FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3) Nestle is withdrawing Nestle Farinha Lactea cereal in the United States. Nestle is taking this action as we have learned that the product may contain residual traces of a pesticide not currently approved for use on wheat in the U.S. While the pesticide is approved for use in Brazil and the noted levels are well below Brazilian standards, it is not used on wheat products in the United States and therefore there is no set standard for its presence in cereal. The pesticide is permitted in the United States on grain crops other than wheat. FDA: data shows no clear heart risk with bone drugs - Forbes FDA: data shows no clear heart risk with bone drugs - Forbes
WASHINGTON (Reuters) - Clinical trial data from four drugmakers shows no overall risk of heart problems in patients taking certain drugs to treat osteoporosis, the Food and Drug Administration said Wednesday. However, the FDA also said it was aware Source: www.forbes.com China recalls another problem drug - Forbes China's drug regulator ordered a nationwide recall of a hemorrhoid medicine Wednesday because of concerns it may cause liver problems in the latest drug problem to hit the country. The State Food and Drug Administration said in a statement on its Web Source: www.forbes.com Your Questions Answered - Associated Press BEIJING (AP) -- China's drug safety watchdog said Thursday it has stopped all production at a company in northeastern China after an herbal injection it sold was suspected of causing the deaths of three people. The State Food and Drug Administration Source: hosted.ap.org FDA staff raises questions on Alpharma drug's design - Newark Star-Ledger Staff members of the Food and Drug Administration have raised concern that an Alpharma painkiller may not curb abuse , despite safeguards in the pill's design, Reuters reported. Alpharma is seeking FDA approval of Embeda , an extended-release form of Source: www.nj.com Studies do not link heart risk to bone drugs: FDA - Reuters WASHINGTON (Reuters) - A review of clinical trial data from four drugmakers shows no overall risk of heart problems in patients taking drugs to treat osteoporosis, the U.S. Food and Drug Administration said on Wednesday. The agency reviewed studies Source: www.reuters.com US FDA staff cite abuse concerns with Alpharma drug - Reuters WASHINGTON, Nov 12 (Reuters) - Alpharma Inc's (ALO.N: Quote , Profile , Research , Stock Buzz ) powerful painkiller Embeda may not thwart drug abusers despite design features aimed at curbing misuse, U.S. regulatory staff said in documents released Source: www.reuters.com UPDATE 1-US FDA staff cite abuse concern with Alpharma drug - Reuters WASHINGTON, Nov 12 (Reuters) - Alpharma Inc's (ALO.N: Quote , Profile , Research , Stock Buzz ) powerful painkiller Embeda may not thwart drug abusers despite design features aimed at curbing misuse, U.S. regulatory staff said in documents released Source: www.reuters.com China recalls capsules suspected of liver damage - Reuters India China recalls capsules suspected of liver damage - Reuters India
BEIJING (Reuters) - China has ordered a hemorrhoid medicine off pharmacy shelves over fears the capsules were to blame for liver problems, state media reported on Wednesday. The State Food and Drug Administration (SFDA) demanded the nationwide recall Source: in.reuters.com China Medical Technologies Receives SFDA Approval for Breast Cancer - MSN MoneyCentral BEIJING , Nov. 12 /Xinhua-PRNewswire-FirstCall/ -- China Medical Technologies, Inc. (the "Company") CMED , a leading China -based medical device company that develops, manufactures and markets advanced in- vitro diagnostic products, today announced Source: news.moneycentral.msn.com Off-Label Prescriptions - CBS42.com (Ivanhoe Newswire) -- When your doctor prescribes a medication, you just assume it’s been fully vetted by the U.S. Food and Drug Administration (FDA). That’s not true in all cases. The FDA approves prescription drugs for specific uses. However Source: www.cbs42.com China stops production at drug company - Seattle Times BEIJING — China's drug safety watchdog said Thursday it has stopped all production at a company in northeastern China after an herbal injection it sold was suspected of causing the deaths of three people. The State Food and Drug Administration said Source: seattletimes.nwsource.com What Happens if You Eat Dog Food? - LiveScience.com If you just eat a little bit of dog food, probably nothing will happen. But you don't really know that for sure because dog food is not subjected to the same health and safety regulations that human food is required to have. In the United States, the Source: www.livescience.com China recalls another drug - Chicago Sun-Times BEIJING---- China's drug regulator ordered a nationwide recall of a hemorrhoid medicine Wednesday because of concerns it may cause liver problems in the latest drug problem to hit the country. The State Food and Drug Administration said in a Source: www.suntimes.com US FDA staff cite abuse concerns with Alpharma drug - Reuters WASHINGTON, Nov 12 (Reuters) - Alpharma Inc's (ALO.N: Quote , Profile , Research , Stock Buzz ) powerful painkiller Embeda may not thwart drug abusers despite design features aimed at curbing misuse, U.S. regulatory staff said in documents released Source: www.reuters.com China recalls another problem drug - San Diego Union-Tribune BEIJING – China's drug regulator ordered a nationwide recall of a hemorrhoid medicine Wednesday because of concerns it may cause liver problems in the latest drug problem to hit the country. The State Food and Drug Administration said in a Source: www.signonsandiego.com Hong Kong Officials Find Toxic Chemical in Fish Feed - Wall Street Journal HONG KONG -- Hong Kong safety officials found elevated levels of a toxic industrial chemical in fish feed from mainland China, though they said they haven't yet found the substance in fish. Hong Kong's Centre for Food Safety said late Tuesday the Source: online.wsj.com SFDA suspends sales of TCM hemorrhoid drug - Interfax Information Agency China SFDA suspends sales of TCM hemorrhoid drug - Interfax Information Agency China
Shanghai. November 12. INTERFAX-CHINA - China's State Food and Drug Administration (SFDA) has ordered sales of a hemorrhoid drug manufactured by Vital Pharmaceutical Holding Ltd. be suspended following 35 adverse drug reaction (ADR) reports, the SFDA Source: www.interfax.cn Independent Data Monitoring Committee Recommends Marshall Edwards, Inc - MSN MoneyCentral The Independent Data Monitoring Committee (IDMC) constituted to oversee the conduct of the Phase III OVArian TUmor REsponse (OVATURE) Trial, yesterday recommended continuation of the study. The OVATURE trial is a major multi-center international Source: news.moneycentral.msn.com China stops production at drug company - Forbes China's drug safety watchdog said Thursday it has stopped all production at a company in northeastern China after an herbal injection it sold was suspected of causing the deaths of three people. The State Food and Drug Administration said Wandashan Source: www.forbes.com China Medical Technologies Receives SFDA Approval for Breast Cancer - MSN MoneyCentral BEIJING , Nov. 12 /Xinhua-PRNewswire-FirstCall/ -- China Medical Technologies, Inc. (the "Company") CMED , a leading China -based medical device company that develops, manufactures and markets advanced in- vitro diagnostic products, today announced Source: news.moneycentral.msn.com Hong Kong Officials Find Toxic Chemical in Fish Feed - Wall Street Journal HONG KONG -- Hong Kong safety officials found elevated levels of a toxic industrial chemical in fish feed from mainland China, though they said they haven't yet found the substance in fish. Hong Kong's Centre for Food Safety said late Tuesday the Source: online.wsj.com China recalls another problem drug - International Herald Tribune BEIJING : China's drug regulator ordered a nationwide recall of a hemorrhoid medicine Wednesday because of concerns it may cause liver problems in the latest drug problem to hit the country. The State Food and Drug Administration said in a statement Source: www.iht.com Does marijuana have spot in Obama agenda? - Chicago Sun-Times Last week, voters in Massachusetts approved a ballot initiative that eliminates criminal penalties for possessing up to an ounce of marijuana, replacing them with a $100 civil fine. Michigan, meanwhile, became the 13th state to allow the medical use Source: www.suntimes.com Off-Label Prescriptions - HealthCentral.com (Ivanhoe Newswire) -- When your doctor prescribes a medication, you just assume it's been fully vetted by the U.S. Food and Drug Administration (FDA). That's not true in all cases. The FDA approves prescription drugs for specific uses. However Source: www.healthcentral.com Catheter Device Used to Correct Heart Rhythm - Wall Street Journal Catheter Device Used to Correct Heart Rhythm - Wall Street Journal
New study data indicate treatment with a catheter-based system made by a Johnson & Johnson unit can help patients avoid recurrence of a common heart-rhythm disorder called atrial fibrillation better than the use of drugs. This is the first Food and Source: online.wsj.com Does marijuana have spot in Obama agenda? - Chicago Sun-Times Last week, voters in Massachusetts approved a ballot initiative that eliminates criminal penalties for possessing up to an ounce of marijuana, replacing them with a $100 civil fine. Michigan, meanwhile, became the 13th state to allow the medical use Source: www.suntimes.com Sanofi-Aventis ends research on troubled diet drug, 2 weeks after - Minneapolis Star Tribune TRENTON, N.J. - French drugmaker Sanofi-Aventis is halting all research on a once-promising diet drug that never made it to the U.S. market. The company says it is stopping all ongoing human testing of the drug, Accomplia, which until recently was Source: www.startribune.com Sanofi-Aventis ends research on troubled diet drug - San Francisco Gate French drugmaker Sanofi-Aventis is halting all research on a once-promising diet drug that never made it to the U.S. market. The company says it is stopping all ongoing human testing of the drug, Accomplia, which until recently was sold in Europe Source: www.sfgate.com UPDATE 1-Pfizer ends development of obesity drug - Forbes NEW YORK, Nov 5 (Reuters) - Pfizer Inc on Wednesday became the latest drugmaker to abandon an obesity treatment that works by blocking the receptors in the brain that makes people hungry after smoking marijuana. The world's largest drugmaker said it Source: www.forbes.com Favorable Endologix Powerlink XL System Clinical Data to Be Announced - MSN MoneyCentral Endologix, Inc. ELGX , the developer and manufacturer of the Powerlink ® System for the minimally invasive treatment of abdominal aortic aneurysms (AAA), today announced that the one-year results from its Powerlink XL ® prospective, multi-center Source: news.moneycentral.msn.com High court should reject vaccine suits POINT OF VIEW: Drug labeling - Daily Oklahoman The Supreme Court recently heard arguments in a case likely to have profound effects on how vaccines are marketed, distributed and developed. The court’s verdict could affirm the existing regulatory framework for testing and labeling vaccines. That Source: newsok.com November 11, 2008CORRECTED - UPDATE 3-Amylin sinks after U.S. FDA rejects data - Reuters CORRECTED - UPDATE 3-Amylin sinks after U.S. FDA rejects data - Reuters
WASHINGTON/LOS ANGELES, Nov 4 (Reuters) - Shares of Amylin Pharmaceuticals Inc (AMLN.O: Quote , Profile , Research , Stock Buzz ) fell more than 20 percent on Tuesday after the biotech company said the U.S. Food and Drug Administration had rejected Source: www.reuters.com BioLife Solutions Submits FDA Master File on HypoThermosol(R - MSN MoneyCentral BOTHELL, Wash. , Nov. 5 /PRNewswire-FirstCall/ -- BioLife Solutions Inc. (OTC Bulletin Board: BLFS), a leading developer and marketer of proprietary hypothermic storage and cryopreservation media products for cells, tissues, and organs, today Source: news.moneycentral.msn.com Now, Sun Pharma under US FDA lens - Times of India NEW DELHI: After Ranbaxy, Sun Pharma's US-based subsidiary, Caraco has come under the glare of US Food and Drug Administration (FDA) for certain manufacturing deficiencies. The FDA has issued a warning letter to Caraco directing the company to report Source: timesofindia.indiatimes.com Amylin shares plunge on FDA study data rejection - Forbes Shares of biotechnology company Amylin Pharmaceuticals Inc. plunged to a new low point Tuesday, after the company said its regulatory approval timeline could be delayed for the much-anticipated diabetes drug exenatide LAR. The stock plummeted $2.76 Source: www.forbes.com Court should stand with injured patients - St. Petersburg Times Consumer protection was on trial before the U.S. Supreme Court last week in a case regarding whether medical patients can sue drug manufacturers in state court if a drug's warning label is incomplete. While Wyeth vs. Levine involves a personal and Source: www.tampabay.com Raptiva (efalizumab) Raptiva (efalizumab)
Risk of life-threatening infections associated with Raptiva use. Recalls and Safety Alerts: Serious Hypersensitivity Reactions with Abacavir (Ziagen) FDA is alerting healthcare professionals that certain patients are more likely to experience serious and potentially fatal hypersensitivity reactions when treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen an... Recalls and Safety Alerts: Updated Warning on Byetta In October 2007, FDA warned healthcare professionals about reports of acute pancreatitis in patients taking the antidiabetic drug Byetta (exenatide). Since then, FDA has received reports of six cases of hemorrhagic or necrotizing pancreatitis in pat... California Fertility Center Gets Warning Letter From FDA - Wall Street Journal California Fertility Center Gets Warning Letter From FDA - Wall Street Journal
WASHINGTON -- A California fertility center received a warning from the Food and Drug Administration for failing to adequately test donors for sexually transmitted diseases, including chlamydia and gonorrhea. The letter, dated Oct. 9 and released Source: online.wsj.com FDA recalls insulin syringes due to mislabeling - Fond du Lac Reporter MADISON -- State heath official are urging people with diabetes and health care professionals to carefully check their insulin syringes. The U.S. Food and Drug Administration (FDA) has recalled one lot of ReliOn sterile, single-use, disposable Source: www.fdlreporter.com Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3) Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3)
Nestle is withdrawing Nestle Farinha Lactea cereal in the United States. Nestle is taking this action as we have learned that the product may contain residual traces of a pesticide not currently approved for use on wheat in the U.S. While the pesticide is approved for use in Brazil and the noted levels are well below Brazilian standards, it is not used on wheat products in the United States and therefore there is no set standard for its presence in cereal. The pesticide is permitted in the United States on grain crops other than wheat. Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella. Nebion HLX-8 Magnetic Resonance Device Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Over The Counter Cough and Cold Medications Product labels being modified to state "do not use" in children under 4 years of age. Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap. New from FDA: FDA?s Drug Safety Newsletter Now Available Every year, FDA receives more than 400,000 reports of adverse events associated with the use of drugs marketed in the U.S. FDA continually reviews these reports to identify signals of potential drug risks. The Drug Safety Newsletter is one way ... Nestle USA Voluntarily Recalls Two Production Codes of Nestle Nesquik Strawberry Powder (November 7) The recall only includes two (2) production codes of 21.8-ounce containers of Nestle Nesquik Strawberry Powder. Printed on the bottom of each plastic container is a production code of "82255880" or "82265880" with a best by date of "August 2010." Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22) Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product. ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets (November 7) ETHEX Corporation announced that it has voluntarily recalled to the consumer level specific lots of five generic/non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5) The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Crestor research results lifesaving - Philadelphia Inquirer Crestor research results lifesaving - Philadelphia Inquirer
They are the kind of results that a drug company prays for: a 54 percent reduction in heart attacks for patients taking AstraZeneca P.L.C.'s Crestor compared with a placebo. A 44 percent reduction in heart problems, such as stroke. But it's far from Source: www.philly.com (Adds researcher comments, details on trial, Abbott strategy) - Reuters NEW ORLEANS, Nov 11 (Reuters) - Abbott Laboratories Inc's (ABT.N: Quote , Profile , Research , Stock Buzz ) experimental drug TriLipix was able to improve cholesterol and triglyceride levels significantly in patients for a year after earlier three Source: www.reuters.com Human-Cell Coating Helps Stent Without Blood Thinner (Update1) - Bloomberg Nov. 11 (Bloomberg) -- A heart stent that coats itself with human tissue kept arteries open without patients needing to take anti-clotting medications, a study found. The stent, made by closely held OrbusNeich , offers an alternative to drug-coated Source: www.bloomberg.com Medivation shares fall on new Dimebon timeline - CNN Money Medivation shares fall on new Dimebon timeline - CNN Money
NEW YORK (Associated Press) - Shares of biotechnology company Medivation Inc. fell Tuesday as the market reacted to an extended timeline for the development program on the lead drug candidate Dimebon. The stock fell $2.27, or 12.2 percent, to $16.43 Source: money.cnn.com Dronedarone (Multaq(R)) Reduced the Incidence and Duration of - MSN MoneyCentral New post-hoc analysis from ATHENA Study showed that Multaq(R) on top of standard therapy significantly decreased the total number of hospital days by 28% in patients with atrial fibrillation or flutter NEW ORLEANS , Nov. 11 /PRNewswire-FirstCall Source: news.moneycentral.msn.com Affymetrix Announces New Cost-effective Product for Standardizing Drug - Genetic Engineering News Affymetrix Announces New Cost-effective Product for Standardizing Drug - Genetic Engineering News
Affymetrix, Inc. ( Nasdaq:AFFX ) today announced the DMET ™ Plus Premier Pack, the most comprehensive method for standardizing drug metabolism studies. The DMET (Drug Metabolism Enzymes and Transporters) Plus Panel features the most biologically Source: www.genengnews.com Test Drug Does Well Against Hospital Infection - Herald Tribune A new antibiotic being developed by a small San Diego company fared well in a clinical trial, holding promise in treating an intestinal superbug that is commonly spread in hospitals and is becoming more deadly. In the trial, the drug developed by Source: www.heraldtribune.com Food poisoned patients recovering in east China - Xinhua News Agency JIAXING, Zhejiang, Nov. 11 (Xinhua) -- Forty-three people sickened in a suspected food poisoning incident left hospitals in Zhejiang Province Tuesday as their situation improved. The other 17 patients, who were kept under medical observation, may Source: news.xinhuanet.com Food Retail Profile of Brazil Presents Competitive Analysis of the - PR Inside - Research and Markets ( www.researchandmarkets.com/research/c46657/food_retail_profil ) has announced the addition of the "Food Retail Profile of Brazil" report to their offering. Food retail sector of a country comprises primarily of hyper Source: www.pr-inside.com Court weighs amputee's case; limits on drug suits - Boston Globe WASHINGTON— The Supreme Court appeared likely Monday to decide an amputee's lawsuit against a drug maker based on how much federal regulators knew about an anti-nausea drug's risks in the event of a botched injection. Several justices indicated Source: www.boston.com GenVec wins fast-track from FDA - Washington Business Journal The Food and Drug Administration has put a pancreatic cancer treatment being developed by GenVec Inc. on a regulatory fast track. The Gaithersburg biotech received the fast-track designation for its TNFerade technology, which uses a DNA carrier to Source: washington.bizjournals.com Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules
See Web site for additional information Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Related information section for posted letter Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks (October 29) Everlasting Distributors Inc., Bayonne NJ is initiating a nationwide recall of all their 3.88oz (110gm) packages of Fresh and Crispy Jacobina Biscuits because it may be contaminated with Melamine. November 10, 2008Transvaginal Placement of Surgical Mesh Transvaginal Placement of Surgical Mesh
Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. Tiotropium (marketed as Spiriva HandiHaler) UPDATE - Preliminary results of the UPLIFT Trial shows no increased risk of stroke with tiotropium bromide. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Improper Use of Decorative Contacts May Haunt You Improper Use of Decorative Contacts May Haunt You
Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision Keeping Watch Over Direct-to-Consumer Ads FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets (November 7) ETHEX Corporation announced that it has voluntarily recalled to the consumer level specific lots of five generic/non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs. Vaccines Stand Ready for Flu Season FDA has approved six vaccines for the 2008-2009 flu season. Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks (October 29) Everlasting Distributors Inc., Bayonne NJ is initiating a nationwide recall of all their 3.88oz (110gm) packages of Fresh and Crispy Jacobina Biscuits because it may be contaminated with Melamine. The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20) The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20)
The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24) Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5) The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22) Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product. Improper Use of Decorative Contacts May Haunt You Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10) Barry Callebaut USA LLC is conducting a voluntary recall on its product sold by Kroger Stores under the brand "Kroger Value Semi Sweet Chocolate Chips", 12 oz., UPC Code is 11110–86603 and "sell by" date May 30, 2010, as the product may contain undeclared milk protein. The "sell by" date is found printed in black on the end of the bag. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product. Caraco gets FDA warning letter on quality control - Forbes Caraco gets FDA warning letter on quality control - Forbes
Generic drugmaker Caraco Pharmaceutical Laboratories Ltd. said Monday it received a warning letter from the Food and Drug Administration over quality-control issues. The letter was issued as a follow-up to an FDA inspection of the company's Detroit Source: www.forbes.com Cathy Betz - Philadelphia Inquirer Cathy Betz, vice president of government affairs for Wolters Kluwer Health, the Conshohocken-based arm of the global health and life-sciences information company, expects big changes - eventually - for the country and regions such as Philadelphia Source: www.philly.com Osmetech Plc ('Osmetech' or the 'Company') Clinical Trials Commence - PR Inside - Osmetech plc (LSE:OMH), the international molecular diagnostics company announces that it has now commenced clinical trials for an extended warfarin sensitivity test. Osmetech obtained clearance from the US Food and Drug Administration (FDA) in Source: www.pr-inside.com Condoms Trump Abstinence in Obama Global AIDS Policy, Aide Says - Bloomberg Nov. 10 (Bloomberg) -- President-elect Barack Obama will reverse U.S. family planning and AIDS prevention strategies that have long linked global funding to anti-abortion and abstinence education, a public-health adviser said. Public health policies Source: www.bloomberg.com Celgene Cellular Therapeutics Receives FDA Clearance for First - MSN MoneyCentral Celgene Cellular Therapeutics (CCT), a wholly owned subsidiary of Celgene Corporation CELG , today announced the U.S. Food and Drug Administration (FDA) has accepted the company ’ s investigational new drug application to initiate a clinical trial Source: news.moneycentral.msn.com Gene-altered animals and food safety - Boston Globe PERHAPS you're still getting used to the idea that some of the meat, milk, and cheese you are eating may come from cloned cows or their offspring, a controversial culinary advance that the Food and Drug Administration green-lighted in January after Source: www.boston.com CNSystems Medizintechnik AG Receives FDA Approval for CNAP(TM) Monitor - Earthtimes GRAZ, Austria - (Business Wire) CNSystems Medizintechnik AG, a medical device company marketing CNAP ™ , today announced that the U.S. Food and Drug Administration has cleared the 510(k) notification for CNSystem's CNAP ™ Monitor 500, permitting Source: www.earthtimes.org Today's Globe: headphones and heart devices, vitamins and heart - Boston Globe If you have a pacemaker or an implanted defibrillator, don't keep your iPod earbuds in your shirt pocket or draped around your neck - even when they're disconnected. Vitamins C and E, pills taken by millions of Americans, do nothing to prevent heart Source: www.boston.com APRISO(TM) Granted FDA Marketing Approval for Maintenance of Remission - MSN MoneyCentral APRISO(TM) Granted FDA Marketing Approval for Maintenance of Remission - MSN MoneyCentral
Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for APRISO(TM) (mesalamine) extended-release capsules 0.375 g. APRISO is a locally-acting aminosalicylate Source: news.moneycentral.msn.com CNSystems Medizintechnik AG Receives FDA Approval for CNAP(TM) Monitor - Genetic Engineering News CNSystems Medizintechnik AG, a medical device company marketing CNAP ™ , today announced that the U.S. Food and Drug Administration has cleared the 510(k) notification for CNSystem's CNAP ™ Monitor 500, permitting the sale of this product in the Source: www.genengnews.com Raptor Pharmaceuticals to Collaborate with Centre Hospitalier - MSN MoneyCentral NOVATO, California , November 10 /PRNewswire/ -- Raptor Pharmaceuticals Corp. ("Raptor" or the "Company") (OTC Bulletin Board: RPTP), today announced that the Company has entered into an agreement with the Centre Hospitalier Universitaire d'Angers Source: news.moneycentral.msn.com India Hot Stocks: Aurobindo Pharma up on U.S. FDA nod - Reuters India MUMBAI, Nov 10 (Reuters) - The following stocks were on the move at the BSE on Monday. At 10:07 a.m., the benchmark 30-share BSE index .BSESN was up 2.41 percent to 10,204.60 points. The 50-share National Stock Exchange Index .NSEI was up 2.56 Source: in.reuters.com FDA burns melamine-tainted products - Bangkok Post Thailand's Food and Drug Administration (FDA) burned eight tonnes of food products tainted with high levels of the toxic chemical melamine on Monday. Deputy Public Health Minister Wicharn Meenchainant witnessed the incineration of tens of thousands Source: www.bangkokpost.com November 9, 2008FDA burns 8 tonnes of melamine-tainted products - Bangkok Post FDA burns 8 tonnes of melamine-tainted products - Bangkok Post
Thailand's Food and Drug Administration (FDA) burned eight tonnes of food products tainted with high levels of the toxic chemical melamine on Monday. Deputy Public Health Minister Wicharn Meenchainan witnessed the incineration of tens of thousands of Source: www.bangkokpost.com FDA Approves Toviaz, a New Drug to Treat Overactive Bladder FDA Approves Toviaz, a New Drug to Treat Overactive Bladder
The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
See Related information section for updated Letter from Mallinckrodt FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection See Web site for additional information Vaccines Stand Ready for Flu Season FDA has approved six vaccines for the 2008-2009 flu season. Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva. Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% See information in Related Information section. November 2008 Patient Safety News November 2008 Patient Safety News
Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Recalls and Melamine Contamination FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. MEOW CHOW 101 - New York Post MEOW CHOW 101 - New York Post
According to a new survey of US pet owners by Harris Interactive for Wellness pet foods, more than 50 percent of pet owners say they always read the label on their own packaged foods, but only 19 percent of them say they read the labels on kitty's Source: www.nypost.com TherOx shows how companies can be forced to move - Detroit Free Press It's got the backing of Silicon Valley's most prominent venture capital firm, has proven that it can reduce heart muscle death in heart attack patients and has filed to go public. So what does California-based TherOx Inc. have to do with Michigan Source: www.freep.com Experts say FDA findings on compound misleading - CNN WASHINGTON (CNN) -- A panel of experts accused the Food and Drug Administration of creating "a false sense of security" with its assessment that a compound used to make food and beverage containers poses no immediate health risks. Bisphenol A is Source: www.cnn.com APRISO(TM) Granted FDA Marketing Approval for Maintenance of Remission - MSN MoneyCentral Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for APRISO(TM) (mesalamine) extended-release capsules 0.375 g. APRISO is a locally-acting aminosalicylate Source: news.moneycentral.msn.com FDA Warns of Dangers of Mexican Vanilla - Atlanta Journal Constitution FRIDAY, Oct. 31 (HealthDay News) -- So-called Mexican "vanilla" is often made with a toxic substance called coumarin and shouldn't be bought by consumers, the U.S. Food and Drug Administration warned this week. Coumarin is related to warfarin, which Source: www.ajc.com FDA Faulted for Stance on Chemical in Plastics - BusinessWeek FRIDAY, Oct. 31 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel agreed Friday that the agency had erred in August when it said that a chemical widely used in baby bottles and other plastic packaging for foods and beverages Source: www.businessweek.com Biotech firms fear pricing pressure from Obama - San Francisco Gate Sunday, November 9, 2008 Obama's victory, and the Democratic party's commanding control of Congress, are expected to put tough pressure on drug prices as the new president tries to realize his campaign vision of expanded health care coverage for Source: www.sfgate.com Caraco gets FDA warning letter on quality control - CNBC DETROIT - Generic drugmaker Caraco Pharmaceutical Laboratories Ltd. said Monday it received a warning letter from the Food and Drug Administration over quality-control issues. The letter was issued as a follow-up to an FDA inspection of the company's Source: www.cnbc.com People's Pharmacy: Does FDA OK give pharmacies a free pass? - Houston Chronicle Does Food and Drug Administration approval guarantee safety? If the Supreme Court rules as expected, patients might have no legal recourse if they are harmed by an FDA-approved medicine. The case that will soon be decided by the Supreme Court Source: www.chron.com |
Subscribe to Posts [Atom]