FDA NEWS

FDA posts list of potential problem drugs - MSNBC

noreply@blogger.com (Network) — Fri, 05 Sep 2008 21:00:00 +0000

FDA posts list of potential problem drugs - MSNBC
WASHINGTON - The government on Friday began posting a list of prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients. The first list is a bare-bones compilation naming 20 medications
Source: www.msnbc.msn.com

Roche hepatitis B test wins U.S. FDA approval - San Diego Union-Tribune
WASHINGTON – Roche Holding AG's DNA test is a safe and effective way to help gauge how well hepatitis B virus treatments are working, U.S. health regulators said on Thursday. The Food and Drug Administration said the test, called the COBAS TaqMan
Source: www.signonsandiego.com

UPDATE 2-U.S. FDA lists drugs under safety probes - Reuters
WASHINGTON, Sept 5 (Reuters) - U.S. health officials have disclosed safety probes into over 20 medicines by companies such as Eli Lilly and Co (LLY.N: Quote , Profile , Research , Stock Buzz ) and Biogen Idec (BIIB.O: Quote , Profile , Research
Source: www.reuters.com

FDA posts list of potential problem drugs - Miami Herald
WASHINGTON In an effort to improve communication with doctors and patients on prescription drug safety, the government Friday began posting a list of medications under investigation for potential problems. The first list is a bare-bones compilation
Source: www.miamiherald.com

Drugs from Biogen, Eli Lilly on FDA review list - CNBC
WASHINGTON - Best-selling drugs from Biogen Idec, Eli Lilly and GlaxoSmithKline are among those under investigation by federal regulators, who have released a first-ever list of ongoing safety reviews. The Food and Drug Administration on Friday
Source: www.cnbc.com

FDA releases list of drugs under investigation - Forbes
The government on Friday began posting a list of prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients. The first list is a bare-bones compilation naming 20 medications and the
Source: www.forbes.com

FACTBOX: Drugs on U.S. FDA list for possible risks - Reuters
(Reuters) - The U.S. Food and Drug Administration on Friday began issuing a list of drugs undergoing safety probes after the agency received reports of health problems. Appearance on the list does not mean the FDA has concluded the drug caused the
Source: www.reuters.com

U.S. FDA lists drugs under safety probes - Forbes
WASHINGTON (Reuters) - U.S. health officials have disclosed safety probes into over 20 medicines by companies such as Eli Lilly and Co (nyse: LLY - news - people ) and Biogen Idec (nasdaq: BIIB - news - people ), a step required by Congress to
Source: www.forbes.com

FDA to List Drugs Under Review for Safety Issues - Washington Post
FRIDAY, Sept. 5 (HealthDay News) -- The U.S. Food and Drug Administration has started listing on its Web site drugs being evaluated for potential safety issues, the agency said Friday. "If a drug appears on a quarterly report, it means we have begun
Source: www.washingtonpost.com

FDA wary of deaths with Pfizer osteoporosis drug - BusinessWeek

noreply@blogger.com (Network) — Fri, 05 Sep 2008 15:00:00 +0000

FDA wary of deaths with Pfizer osteoporosis drug - BusinessWeek
Federal regulators say a drug from Pfizer and Ligand Pharmaceuticals effectively treats osteoporosis, though they are concerned about deaths, blood clots and other problems seen in company studies. The Food and Drug Administration noted Thursday that
Source: www.businessweek.com

Vytorin Study's Ethical Morass - Forbes
Cardiologists and statisticians are arguing about whether the cholesterol drug Vytorin might increase the rate of cancer deaths. But experts on both sides of the argument agree on one thing: They don’t like the way the results were made public
Source: www.forbes.com

Cancer risk of anti-cholesterol drug Inergy played down - Guardian Unlimited
Heart experts today played down fears that an anti-cholesterol drug could cause cancer. A study, published in the New England Journal of Medicine, linked Inergy, a combination of two statins, to an increased risk of developing cancer. But the British
Source: www.guardian.co.uk

Gov't questions safety of plastic in baby bottles - San Diego Union-Tribune
WASHINGTON – Government toxicologists have reiterated safety concerns about a chemical used in baby bottles and food containers, just weeks after the Food and Drug Administration declared the substance safe. A report issued Wednesday said there is
Source: www.signonsandiego.com

Regulatory review of ViroPharma-Lev tie-up ends - CNBC
CAMBRIDGE, Mass. - ViroPharma Inc. said Wednesday that a federal regulatory period has expired, allowing the company to proceed with its buyout of Lev Pharmaceuticals Inc. The Federal Trade Commission waiting period required under the Hart-Scott
Source: www.cnbc.com

FDA: Offspring of Cloned Cattle May Be in Food Supply - Retail Wire
The U.S. Food and Drug Administration (FDA) is on record stating that there is no difference between meat and milk from cloned animals and those of the originals. Even so, ranchers have followed a voluntary moratorium on the sale of clones and their
Source: www.retailwire.com

Roche hepatitis B test wins U.S. FDA approval - San Diego Union-Tribune
WASHINGTON – Roche Holding AG's DNA test is a safe and effective way to help gauge how well hepatitis B virus treatments are working, U.S. health regulators said on Thursday. The Food and Drug Administration said the test, called the COBAS TaqMan
Source: www.signonsandiego.com

Edwards Lifesciences Receives FDA Approval for PERIMOUNT Magna Mitral - MSN MoneyCentral
Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Carpentier-Edwards PERIMOUNT Magna mitral heart valve
Source: news.moneycentral.msn.com

Concentric Named Professional Agency of Record for Discovery Labs - Forbes
NEW YORK, Sept. 3 /PRNewswire/ -- Concentric Pharma Advertising, one of the fastest growing marketing agencies in the healthcare field, has been named agency of record by Discovery Labs for SURFAXIN(R) (lucinactant), an investigational drug being
Source: www.forbes.com

FDA Wants Stronger Warnings On Arthritis Drugs - E Canada Now

noreply@blogger.com (Network) — Fri, 05 Sep 2008 13:00:00 +0000

FDA Wants Stronger Warnings On Arthritis Drugs - E Canada Now
Washington (ECN) - The FDA has come out and ordered stronger warnings to be added to arthritis and autoimmune drugs from major companies. The stronger warnings need to be placed on arthritis and autoimmune drugs from Amgen, Wyeth, and Johnson
Source: www.ecanadanow.com

4 arthritis drugs get tougher warnings - Seattle Times

noreply@blogger.com (Network) — Fri, 05 Sep 2008 11:00:00 +0000

4 arthritis drugs get tougher warnings - Seattle Times
The Food and Drug Administration (FDA) ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections. The caution, the
Source: seattletimes.nwsource.com

Inverness Medical Launches Portable Blood Testing Monitor to Warn - Forbes
Inverness Medical Physician Diagnostics Group, a division of Inverness Medical Innovations, today announced the launch of the INRatio(R)2 PT/INR Monitoring System, a portable device that measures blood-clotting time, also known as prothrombin time
Source: www.forbes.com

Republican Convention report card: John McCain - CNN
1 McCain: 'Fight with me' 2 Analysis: McCain short on answers 3 Icy fuel lines behind plane crash 4 Cubans held in Mexico beheadings 5 Hanna closes in on U.S. 6 Pakistan protests 'cowardly' acts 7 RNC report card: John McCain 8 China: Flaws in
Source: edition.cnn.com

Clones' offspring may be in food supply: FDA - Reuters
WASHINGTON (Reuters) - Food and milk from the offspring of cloned animals may have entered the U.S. food supply, the U.S. government said on Tuesday, but it would be impossible to know because there is no difference between cloned and conventional
Source: www.reuters.com

Arthritis-drug warnings ordered - Philadelphia Inquirer
WASHINGTON - The Food and Drug Administration ordered stronger warnings yesterday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying the medicines could raise the risk of possibly fatal fungal infections
Source: www.philly.com

FDA wary of deaths with new Pfizer drug - New London Day
Federal regulators say a drug from Pfizer and Ligand Pharmaceuticals effectively treats osteoporosis, though they are concerned about deaths, blood clots and other problems seen in company studies. The Food and Drug Administration noted Thursday that
Source: www.theday.com

FDA Plans Stronger Warnings - Tampa Bay Online
WASHINGTON - The Food and Drug Administration ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections. The drugs
Source: www2.tbo.com

Inhaled Treprostinil New Drug Application Filed by FDA - Forbes
SILVER SPRING, Md., Sept. 3 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR) and its wholly-owned subsidiary Lung Rx, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug
Source: www.forbes.com

Angola denies ship from unloading weapons - CNN
(CNN) -- Angola's government has denied permission for a Chinese ship to unload weapons destined for Zimbabwe at its port, the latest country to do so, the nation's state-run ANGOP news agency reported. The ship was allowed to dock at the port of
Source: edition.cnn.com

Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia)

noreply@blogger.com (Network) — Fri, 05 Sep 2008 09:00:00 +0000

Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia)
Report of SEAS trial of a possible association between the use of Vytorin and a potential increased incidence of cancer.

FDA Extends Consumer Warning on Serrano Peppers from Mexico

noreply@blogger.com (Network) — Fri, 05 Sep 2008 05:00:00 +0000

Edwards Lifesciences Receives FDA Approval for PERIMOUNT Magna Mitral - MSN MoneyCentral

noreply@blogger.com (Network) — Fri, 05 Sep 2008 03:00:00 +0000

Edwards Lifesciences Receives FDA Approval for PERIMOUNT Magna Mitral - MSN MoneyCentral
Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Carpentier-Edwards PERIMOUNT Magna mitral heart valve
Source: news.moneycentral.msn.com

Vytorin Study's Ethical Morass - Forbes
Cardiologists and statisticians are arguing about whether the cholesterol drug Vytorin might increase the rate of cancer deaths. But experts on both sides of the argument agree on one thing: They don’t like the way the results were made public
Source: www.forbes.com

FDA: Offspring of Cloned Cattle May Be in Food Supply - Retail Wire
The U.S. Food and Drug Administration (FDA) is on record stating that there is no difference between meat and milk from cloned animals and those of the originals. Even so, ranchers have followed a voluntary moratorium on the sale of clones and their
Source: www.retailwire.com

Study: Heart rhythm drug cuts stroke risk by 1/3 - Boston Globe
BRIDGEWATER, N.J. -- An experimental drug to treat irregular heart rhythm reduced the risk of stroke by one-third, according to data presented at the European Society of Cardiology conference Wednesday. The drug, known by the brand name Multaq and
Source: www.boston.com

Concentric Named Professional Agency of Record for Discovery Labs - Forbes
NEW YORK, Sept. 3 /PRNewswire/ -- Concentric Pharma Advertising, one of the fastest growing marketing agencies in the healthcare field, has been named agency of record by Discovery Labs for SURFAXIN(R) (lucinactant), an investigational drug being
Source: www.forbes.com

Patients advised to keep taking Inegy cholesterol therapy despite - Times Online
Patients have been advised to carry on taking an anti-cholesterol treatment despite research that suggested it may be linked to higher cancer rates. Inegy, a therapy that combines simvastatin with another drug called ezetimibe, was linked to slightly
Source: www.timesonline.co.uk

Government questions safety of plastic baby bottles - Dallas Morning News
WASHINGTON (AP) -- Government toxicologists have reiterated safety concerns about a chemical used in baby bottles and food containers, just weeks after the Food and Drug Administration declared the substance safe. A report issued Wednesday said there
Source: www.dallasnews.com

FDA OKs Medtronic system to find ICD lead cracks - Reuters
CHICAGO, Sept 4 (Reuters) - The U.S. Food and Drug Administration on Thursday said it approved a software update from Medtronic Inc (MDT.N: Quote , Profile , Research , Stock Buzz ) that will help detect fractures of the company's Sprint Fidelis
Source: www.reuters.com

Regulatory review of ViroPharma-Lev tie-up ends - CNBC
CAMBRIDGE, Mass. - ViroPharma Inc. said Wednesday that a federal regulatory period has expired, allowing the company to proceed with its buyout of Lev Pharmaceuticals Inc. The Federal Trade Commission waiting period required under the Hart-Scott
Source: www.cnbc.com

Cancer risk of anti-cholesterol drug Inergy played down - Guardian Unlimited
Heart experts today played down fears that an anti-cholesterol drug could cause cancer. A study, published in the New England Journal of Medicine, linked Inergy, a combination of two statins, to an increased risk of developing cancer. But the British
Source: www.guardian.co.uk

FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections

noreply@blogger.com (Network) — Thu, 04 Sep 2008 22:00:00 +0000

FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

QFC Recalling Deli Tuna Salad Items in Washington and Oregon (August 28)
Quality Food Centers (QFC) said today it is recalling five deli tuna salad items sold at some QFC stores in Washington and Oregon.

Interior Alaska Fish Processors, Inc. Recalls Santa's Smokehouse Brand Smoked Keta Salmon (August 13)
The recalled product was sold in random weight portions and packaged in clear plastic vacuum sealed bags with the Santa's Smokehouse "teriyaki style smoked keta salmon" label on it. The only batch subject to the recall will be labeled with the batch number '637', found on the Santa's Smokehouse label.

FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder
The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.

S and M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Brand Dried Bamboo Fungus Veiled Lady (August 12)
The recall was initiated after routine sampling by New York State Department of Agriculture and Markets food inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in Grove Grow Notes brand Dried Bamboo Fungus Veiled Lady which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites

FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts

noreply@blogger.com (Network) — Thu, 04 Sep 2008 16:00:00 +0000

FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts
The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.

Safety and Food Packaging
FDA monitors all packaging that comes into contact with food. Here's an overview of how FDA conducts safety reviews of food contact substances.

FDA Law Enforcers Crack Down on Illegal Botox Scammer
FDA's Office of Criminal Investigations found physicians who put profit before patients when they injected them with fake Botox Cosmetic.

Are You Storing Food Safely?
When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards.

FDA Approves First Drug for Treatment of Chorea in Huntington's Disease
The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington's disease. Chorea is the jerky, involuntary movement that occurs in people with this disease.

Recalls and Safety Alerts: Severe Pain with Osteoporosis Drugs (March 2008)
This story originally aired in March 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. FDA is alerting healthcare professionals that severe bone, join...

FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

Warning on Certain Mussel Products from Bantry Bay Seafood
FDA is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods because they may be contaminated with azaspiracid toxins.

FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley
The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP).

Clones' offspring may be in food supply: FDA - Reuters

noreply@blogger.com (Network) — Thu, 04 Sep 2008 14:00:00 +0000

Clones' offspring may be in food supply: FDA - Reuters
WASHINGTON (Reuters) - Food and milk from the offspring of cloned animals may already have entered the U.S. food supply, the Food and Drug Administration said on Monday, but it would be impossible to know because there is no difference between cloned
Source: www.reuters.com

India's Strides Arcolab wins U.S. FDA approval for 2 anti-inflammatory - CNBC
MUMBAI (Thomson Financial) - India's Strides Arcolab Ltd. said the U.S. Food and Drug Administration (FDA) has approved two of the company's anti-inflammatory corticosteroids. The FDA has approved the abbreviated new drug applications (ANDA) for
Source: www.cnbc.com

ZYBRESTAT Named One of the 10 Most Interesting Oncology Projects - MSN MoneyCentral
WALTHAM, Mass., Sept. 4, 2008 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), (XSSE:OXGN) today announced that ZYBRESTAT(tm) (fosbretabulin), the company's lead therapeutic product candidate, has been selected by Windhover Information and an
Source: news.moneycentral.msn.com

Akorn gets FDA approval for dexamethasone sodium phosphate injection - CNBC
NEW YORK (Thomson Financial) - Akorn-Strides, LLC Tuesday said its received approval from the Food and Drug Administration for its dexamethasone sodium phosphate injection in 4mg and 10mg base form, which treats such conditions as endocrine disorders
Source: www.cnbc.com

Chemical in Plastic Is Connected to Health Problems in Monkeys - Washington Post
Researchers at the Yale School of Medicine have linked a chemical found in everyday plastics to problems with brain function and mood disorders in monkeys -- the first time the chemical has been connected to health problems in primates. The study is
Source: www.washingtonpost.com

Stewart subpoena not ruled out - Baltimore Sun
WASHINGTON - Lawmakers leading an investigation of Martha Stewart's sale of ImClone Systems Inc. stock aren't ruling out issuing a subpoena to force her to appear on Capitol Hill. "It may be the only means to get her to come forward and tell her
Source: www.baltimoresun.com

Patients advised to keep taking Inegy cholesterol therapy despite - Times Online

noreply@blogger.com (Network) — Thu, 04 Sep 2008 07:00:00 +0000

Patients advised to keep taking Inegy cholesterol therapy despite - Times Online
Patients have been advised to carry on taking an anti-cholesterol treatment despite research that suggested it may be linked to higher cancer rates. Inegy, a therapy that combines simvastatin with another drug called ezetimibe, was linked to slightly
Source: www.timesonline.co.uk

Study: Heart rhythm drug cuts stroke risk by 1/3 - Boston Globe
BRIDGEWATER, N.J. -- An experimental drug to treat irregular heart rhythm reduced the risk of stroke by one-third, according to data presented at the European Society of Cardiology conference Wednesday. The drug, known by the brand name Multaq and
Source: www.boston.com

Edwards Lifesciences Receives FDA Approval for PERIMOUNT Magna Mitral - MSN MoneyCentral
Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Carpentier-Edwards PERIMOUNT Magna mitral heart valve
Source: news.moneycentral.msn.com

Concentric Named Professional Agency of Record for Discovery Labs - Forbes
NEW YORK, Sept. 3 /PRNewswire/ -- Concentric Pharma Advertising, one of the fastest growing marketing agencies in the healthcare field, has been named agency of record by Discovery Labs for SURFAXIN(R) (lucinactant), an investigational drug being
Source: www.forbes.com

Vytorin Study's Ethical Morass - Forbes
Cardiologists and statisticians are arguing about whether the cholesterol drug Vytorin might increase the rate of cancer deaths. But experts on both sides of the argument agree on one thing: They don’t like the way the results were made public
Source: www.forbes.com

Edwards Lifesciences Receives FDA Approval for PERIMOUNT Magna Mitral - MSN MoneyCentral

noreply@blogger.com (Network) — Thu, 04 Sep 2008 04:00:00 +0000

Making Sense of Vytorin Concerns

noreply@blogger.com (Network) — Wed, 03 Sep 2008 13:00:00 +0000

Making Sense of Vytorin Concerns
This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications.

Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection
See Web site for additional information on this current drug shortage

FDA 101: Dietary Supplements
Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers.

FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample
The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database.

FDA Law Enforcers Protect Consumers' Health
Inside the FDA's Office of Criminial Investigations

FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

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.

FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley
The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP).

FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15)
The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps.

Drug Shortage: MVI Adult Injectable
Hospira information updated.

Strides Arcolab gets US FDA nod for 2 more products - Reuters India

noreply@blogger.com (Network) — Wed, 03 Sep 2008 08:00:00 +0000

Strides Arcolab gets US FDA nod for 2 more products - Reuters India
MUMBAI (Reuters) - Strides Arcolab Ltd said on Tuesday it has got approval from the U.S. Food and Drug Administration for two more drugs, thereby taking the total approvals to 11. The drugs that have got approvals are Dexamethasone injection and
Source: in.reuters.com

DRIVEN TO SUICIDE: Suicide risks studied in drugs for physical ills - Times & Democrat
WASHINGTON -- Cody Miller was a high school football player who was allergic to ragweed. Douglas Briggs was a doctor coping with pain from an old back injury. Both are now dead, hanging victims driven to suicide, their families believe, when drugs
Source: www.timesanddemocrat.com

India's Strides Arcolab wins U.S. FDA approval for 2 anti-inflammatory - CNBC
MUMBAI (Thomson Financial) - India's Strides Arcolab Ltd. said the U.S. Food and Drug Administration (FDA) has approved two of the company's anti-inflammatory corticosteroids. The FDA has approved the abbreviated new drug applications (ANDA) for
Source: www.cnbc.com

Clones' Offspring May Be in Food Supply: FDA - ABC News
WASHINGTON (Reuters) - Food and milk from the offspring of cloned animals may have entered the U.S. food supply, the U.S. government said on Tuesday, but it would be impossible to know because there is no difference between cloned and conventional
Source: www.abcnews.go.com

Clones' offspring may be in U.S. food supply: government - Reuters
WASHINGTON (Reuters) - Food and milk from the offspring of cloned animals may already have entered the U.S. food supply, the Food and Drug Administration said on Monday, but it would be impossible to know because there is no difference between cloned
Source: www.reuters.com

Sandoz receives FDA approval for Omnitrope® Pen 10 with liquid - Asia Corporate News Network
Corporate news announcement processed and transmitted by Hugin ASA. The issuer is solely responsible for the content of this announcement. ----- ----- * New 10mg strength
Source: www.acnnewswire.com

Supplement makers need stricter FDA oversight - Los Angeles Times
» Discuss Article When I read about the founder of Berkeley Premium Nutraceuticals being sentenced last week to 25 years in prison for defrauding customers with dubious herbal remedies, I asked myself yet again: Why doesn't the government regulate
Source: www.latimes.com

CSMG Technologies Subsidiary Live Tissue Connect Awarded European - Forbes
CSMG Technologies (OTCBB: CTGI), a technology management company, announced its subsidiary, Live Tissue Connect Technologies (LTC), has been awarded CE Mark (Conformite Europeene) certification for its Bipolar Forceps by BSI Product Services in its
Source: www.forbes.com

Akorn gets FDA approval for dexamethasone sodium phosphate injection - CNBC
NEW YORK (Thomson Financial) - Akorn-Strides, LLC Tuesday said its received approval from the Food and Drug Administration for its dexamethasone sodium phosphate injection in 4mg and 10mg base form, which treats such conditions as endocrine disorders
Source: www.cnbc.com

Clones' offspring may be in US food supply - govt - Forbes
WASHINGTON (Reuters) - Food and milk from the offspring of cloned animals may already have entered the U.S. food supply, the Food and Drug Administration said on Monday, but it would be impossible to know because there is no difference between cloned
Source: www.forbes.com

Whole Foods Market Issues Recall on 365 Organic Everyday Value Popcorn, Lightly Salted Due to Undeclared Dairy Allergen (August 14)

noreply@blogger.com (Network) — Wed, 03 Sep 2008 04:00:00 +0000

Whole Foods Market Issues Recall on 365 Organic Everyday Value Popcorn, Lightly Salted Due to Undeclared Dairy Allergen (August 14)
This product was distributed to and sold in Whole Foods Market retail stores in California, Arizona, Nevada, Kentucky, Maryland, Ohio, Pennsylvania, Virginia, Washington D.C, Connecticut, Maine, Massachusetts, Rhode Island, Oregon, New Jersey, New York and Washington.

Fentanyl Transdermal System CII Patches
UPDATE - Voluntary recall because one lot of the product contained patches leaking fentanyl gel.

QFC Recalling Deli Tuna Salad Items in Washington and Oregon (August 28)
Quality Food Centers (QFC) said today it is recalling five deli tuna salad items sold at some QFC stores in Washington and Oregon.

Federal Agents Seize more than $24 Million in Unapproved New Drugs
Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28)
Jack Distribution, LLC, and its wholesale distributors G and N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL".

FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder
The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.

FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts
The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.

FDA Extends Consumer Warning on Serrano Peppers from Mexico
Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States.

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)
UPDATE - Dear Healthcare Professional letter added.

Akorn gets FDA approval for dexamethasone sodium phosphate injection - Forbes

noreply@blogger.com (Network) — Wed, 03 Sep 2008 02:00:00 +0000

Akorn gets FDA approval for dexamethasone sodium phosphate injection - Forbes
NEW YORK (Thomson Financial) - Akorn-Strides, LLC Tuesday said its received approval from the Food and Drug Administration for its dexamethasone sodium phosphate injection in 4mg and 10mg base form, which treats such conditions as endocrine disorders
Source: www.forbes.com

Profile: Worldwide Clinical Research helps patients around the globe - Kansas City Star

noreply@blogger.com (Network) — Tue, 02 Sep 2008 07:00:00 +0000

Profile: Worldwide Clinical Research helps patients around the globe - Kansas City Star
“We are an extension of our clients,” Barb Geiger, president of Worldwide Clinical Research in Overland Park, said of managing clinical trials all over the world. As a nursing student in the pediatric unit at the University of Kansas Medical
Source: www.kansascity.com

Last week's headlines - Baltimore Sun
Two years after taking over 10 Macy's stores, including three in the Baltimore market, the Boscov's department store chain is wrestling with a "perfect storm" of slowed consumer spending and the credit crunch. Kenneth S. Lakin, chairman of the
Source: www.baltimoresun.com

Suicide Risk Of Certain Drugs Under FDA Investigation - Redorbit.com
Federal investigators are currently investigating claims that certain drugs prescribed for asthma, controlling seizures or quitting smoking may be linked to a high risk of suicide. Food and Drug Administration officials have already been actively
Source: www.redorbit.com

Injections of Hope Doctors Promote Offshore Stem Cell Shots, but Some - Washington Post
Avast human experiment is afoot. And no one is taking good notes. Fueled by demand from desperate patients, dozens of companies around the globe are peddling stem cell injections for $15,000 to $50,000 and more. Based merely on the claims made by
Source: www.washingtonpost.com

Prasugrel seen better for diabetes patients than Plavix - Reuters
MUNICH, Aug 31 (Reuters) - Eli Lilly (LLY.N: Quote , Profile , Research , Stock Buzz ) and Daiichi Sankyo's (4568.T: Quote , Profile , Research , Stock Buzz ) new blood-thinning drug prasugrel appears better for diabetes patients than Plavix
Source: www.reuters.com

Contraceptive Fudge: Addendum - Slate
Friday morning, an investigator from the Food and Drug Administration spent four hours questioning Jennalee Ryan of San Antonio, Texas, about her new line of business. That business, outlined a week ago by Washington Post reporter Rob Stein, is
Source: www.slate.com

Injections of Hope - Washington Post
Barbara Hanson says she paid about $17,000 for injections at a Mexican clinic to treat her chronic obstructive pulmonary disease. (Barbara Hanson) Barbara Hanson, here with her husband, Lorin, says the treatment she got in Mexico made her ill. "It
Source: www.washingtonpost.com

60' note may back Stewart's story - Baltimore Sun
NEW YORK - Congressional investigators have obtained a document from Merrill Lynch that sheds light on style guru Martha Stewart's alleged early plans to sell her ImClone Systems Inc. stock. It mentions $60 -- the price at which Stewart says she
Source: www.baltimoresun.com

Watch out for drug names that look, sound alike - FOX News
WASHINGTON — Take the generic drug clonidine for high blood pressure? Double-check that you didn't leave the drugstore with Klonopin for seizures, or the gout medicine colchicine. Mixing up drug names because they look or sound alike _ like this
Source: www.foxnews.com

Smoked salmon recalled after bacteria detected - Pittsburgh Post-Gazette
A Bellingham, Wash., seafood company is recalling 4-ounce packages of smoked salmon with pepper that were distributed in seven states, including Pennsylvania. The recall of "Cracked Pepper Style Smoked Salmon" lot number 54933-2 made by Trans-Ocean
Source: www.post-gazette.com

Mylan to launch generic Alzheimer's drug - Forbes

noreply@blogger.com (Network) — Tue, 02 Sep 2008 02:00:00 +0000

Mylan to launch generic Alzheimer's drug - Forbes
Mylan Inc. said Friday it is immediately launching a generic version of the Alzheimer's disease drug Razadyne after receiving regulatory approval and a favorable court ruling. The original drug is made by Ortho-McNeil Neurologics, a unit of Johnson
Source: www.forbes.com

Hi-Tech Pharmacal Files Suit to Confirm the Company's Market - MSN MoneyCentral
Hi-Tech Pharmacal Co., Inc. HITK announced that the Company filed a complaint in the U.S. District Court for the District of Columbia against the U.S. Food and Drug Administration (FDA) requesting a declaratory judgment related to Hi-Tech ’ s
Source: news.moneycentral.msn.com

Debate over food irradiation still simmering - Minneapolis Star Tribune
A fter two years of nearly constant food-borne illness outbreaks and recalls of everything from tainted peanut butter to tons of hamburger meat, the Food and Drug Administration's decision this month to allow the irradiation of lettuce and spinach to
Source: www.startribune.com

ACC Applauds California's Decision to Not Ban Food-Contact Products - PR Newswire
ARLINGTON, Va., Aug. 30 /PRNewswire-USNewswire/ -- The American Chemistry Council (ACC) applauds the California Assembly for listening to scientific experts and not passing SB1713 -- a bill that would have needlessly removed safe and essential
Source: sev.prnewswire.com

Is it Mutant or Health Food? - ABC News
Don't expect to find irradiated spinach and lettuce in your supermarket any time soon, even though federal regulators have given the food industry permission to sell it. Food producers aren't going to be rushing to irradiate our meals anytime soon
Source: abcnews.go.com

Mylan to launch generic Alzheimer's drug - BusinessWeek
Mylan Inc. said Friday it is immediately launching a generic version of the Alzheimer's disease drug Razadyne after receiving regulatory approval and a favorable court ruling. The original drug is made by Ortho-McNeil Neurologics, a unit of Johnson
Source: www.businessweek.com

GlaxoSmithKline drug ad sparks a debate - Philadelphia Inquirer
"DON'T BE FOOLED: GlaxoSmithKline's scare tactics are only concerned with protecting its profit, not the health of people with HIV/AIDS," the ads read. The AIDS Healthcare Foundation (AHF) is running the spots in the Washington Blade, the Village
Source: www.philly.com

Hi-Tech files for decision on drug exclusivity - Forbes
Generic drug developer and nutritional products company Hi-Tech Pharmacal Co. said Thursday it asked a district court to rule that it is eligible for 180 days of market exclusivity for a generic version of Merck 's glaucoma treatment Cosopt. The
Source: www.forbes.com

Salmonella outbreak appears to be over, CDC says - Houston Chronicle
WASHINGTON — The Centers for Disease Control and Prevention say the salmonella outbreak that sickened more than 1,440 people appears to be over. A joint investigation by CDC and the Food and Drug Administration found strong evidence that jalapeno
Source: www.chron.com

Dr Reddy's gets FDA nod for trandolapril tabs - Reuters India
MUMBAI (Reuters) - Indian drug maker Dr Reddy's Laboratories Ltd has received approval from the U.S. Food and Drug Administration for trandolapril tablets, the regulator's website showed. The drug is a generic version of Abbott Laboratories' Mavik
Source: in.reuters.com

Hi-Tech files for decision on drug exclusivity - Forbes

noreply@blogger.com (Network) — Mon, 01 Sep 2008 23:00:00 +0000

Hi-Tech files for decision on drug exclusivity - Forbes
Generic drug developer and nutritional products company Hi-Tech Pharmacal Co. said Thursday it asked a district court to rule that it is eligible for 180 days of market exclusivity for a generic version of Merck 's glaucoma treatment Cosopt. The
Source: www.forbes.com

GlaxoSmithKline drug ad sparks a debate - Philadelphia Inquirer
"DON'T BE FOOLED: GlaxoSmithKline's scare tactics are only concerned with protecting its profit, not the health of people with HIV/AIDS," the ads read. The AIDS Healthcare Foundation (AHF) is running the spots in the Washington Blade, the Village
Source: www.philly.com

Mylan to launch generic Alzheimer's drug - BusinessWeek
Mylan Inc. said Friday it is immediately launching a generic version of the Alzheimer's disease drug Razadyne after receiving regulatory approval and a favorable court ruling. The original drug is made by Ortho-McNeil Neurologics, a unit of Johnson
Source: www.businessweek.com

Salmonella outbreak appears to be over, CDC says - Houston Chronicle
WASHINGTON — The Centers for Disease Control and Prevention say the salmonella outbreak that sickened more than 1,440 people appears to be over. A joint investigation by CDC and the Food and Drug Administration found strong evidence that jalapeno
Source: www.chron.com

Debate over food irradiation still simmering - Minneapolis Star Tribune
A fter two years of nearly constant food-borne illness outbreaks and recalls of everything from tainted peanut butter to tons of hamburger meat, the Food and Drug Administration's decision this month to allow the irradiation of lettuce and spinach to
Source: www.startribune.com

Hop Lee Trading Co., Inc. Issues Alert on Undeclared Sulfites in Flower Brand Dried Sweet Potato (August 12)

noreply@blogger.com (Network) — Mon, 01 Sep 2008 19:01:00 +0000

Hop Lee Trading Co., Inc. Issues Alert on Undeclared Sulfites in Flower Brand Dried Sweet Potato (August 12)
Hop Lee Trading Co. Inc. is recalling Flower brand Dried Sweet Potato because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

Current Drug Shortage: Proglycem (diazoxide) oral suspension
Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652

Vivitrol (naltrexone)
Serious injection site reactions may occur with the use of injectable naltrexone.

Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection)
Baxter has discontinued Revex production.

FDA Extends Consumer Warning on Serrano Peppers from Mexico

noreply@blogger.com (Network) — Mon, 01 Sep 2008 14:00:00 +0000

FDA Extends Consumer Warning on Serrano Peppers from Mexico
Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States.

Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection)
Baxter has discontinued Revex production.

Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection
See Web site for additional information on this current drug shortage

FDA Approves 2008-2009 Flu Vaccines
The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season. The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone.

Preventing Medical Errors: What to Do about Unretrieved Device Fragments (January 2008)
This story originally aired in January 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent FDA article in the journal Nursing2007 alerts health...

FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample
The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database.

Preventing Medical Errors: More Patient Deaths from Luer Misconnections (October 2007)
This story originally aired in October 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent FDA article in the publication "Safe Practices in Pa...

Is it Mutant or Health Food? - ABC News

noreply@blogger.com (Network) — Mon, 01 Sep 2008 03:00:00 +0000

Is it Mutant or Health Food? - ABC News
Don't expect to find irradiated spinach and lettuce in your supermarket any time soon, even though federal regulators have given the food industry permission to sell it. Food producers aren't going to be rushing to irradiate our meals anytime soon
Source: abcnews.go.com

Salmonella outbreak appears to be over, CDC says - Houston Chronicle
WASHINGTON — The Centers for Disease Control and Prevention say the salmonella outbreak that sickened more than 1,440 people appears to be over. A joint investigation by CDC and the Food and Drug Administration found strong evidence that jalapeno
Source: www.chron.com

Hi-Tech files for decision on drug exclusivity - Forbes
Generic drug developer and nutritional products company Hi-Tech Pharmacal Co. said Thursday it asked a district court to rule that it is eligible for 180 days of market exclusivity for a generic version of Merck 's glaucoma treatment Cosopt. The
Source: www.forbes.com

Mylan to launch generic Alzheimer's drug - Forbes

noreply@blogger.com (Network) — Sun, 31 Aug 2008 18:00:00 +0000

Mylan to launch generic Alzheimer's drug - Forbes
Mylan Inc. said Friday it is immediately launching a generic version of the Alzheimer's disease drug Razadyne after receiving regulatory approval and a favorable court ruling. The original drug is made by Ortho-McNeil Neurologics, a unit of Johnson
Source: www.forbes.com

Dr Reddy's gets FDA nod for trandolapril tabs - Reuters India
MUMBAI (Reuters) - Indian drug maker Dr Reddy's Laboratories Ltd has received approval from the U.S. Food and Drug Administration for trandolapril tablets, the regulator's website showed. The drug is a generic version of Abbott Laboratories' Mavik
Source: in.reuters.com

Hi-Tech Pharmacal Files Suit to Confirm the Company's Market - MSN MoneyCentral
Hi-Tech Pharmacal Co., Inc. HITK announced that the Company filed a complaint in the U.S. District Court for the District of Columbia against the U.S. Food and Drug Administration (FDA) requesting a declaratory judgment related to Hi-Tech ’ s
Source: news.moneycentral.msn.com

GlaxoSmithKline drug ad sparks a debate - Philadelphia Inquirer
"DON'T BE FOOLED: GlaxoSmithKline's scare tactics are only concerned with protecting its profit, not the health of people with HIV/AIDS," the ads read. The AIDS Healthcare Foundation (AHF) is running the spots in the Washington Blade, the Village
Source: www.philly.com

Salmonella outbreak appears to be over, CDC says - Houston Chronicle
WASHINGTON — The Centers for Disease Control and Prevention say the salmonella outbreak that sickened more than 1,440 people appears to be over. A joint investigation by CDC and the Food and Drug Administration found strong evidence that jalapeno
Source: www.chron.com

Mylan to launch generic Alzheimer's drug - BusinessWeek
Mylan Inc. said Friday it is immediately launching a generic version of the Alzheimer's disease drug Razadyne after receiving regulatory approval and a favorable court ruling. The original drug is made by Ortho-McNeil Neurologics, a unit of Johnson
Source: www.businessweek.com

Is it Mutant or Health Food? - ABC News
Don't expect to find irradiated spinach and lettuce in your supermarket any time soon, even though federal regulators have given the food industry permission to sell it. Food producers aren't going to be rushing to irradiate our meals anytime soon
Source: abcnews.go.com

Hi-Tech files for decision on drug exclusivity - Forbes
Generic drug developer and nutritional products company Hi-Tech Pharmacal Co. said Thursday it asked a district court to rule that it is eligible for 180 days of market exclusivity for a generic version of Merck 's glaucoma treatment Cosopt. The
Source: www.forbes.com

ACC Applauds California's Decision to Not Ban Food-Contact Products - PR Newswire
ARLINGTON, Va., Aug. 30 /PRNewswire-USNewswire/ -- The American Chemistry Council (ACC) applauds the California Assembly for listening to scientific experts and not passing SB1713 -- a bill that would have needlessly removed safe and essential
Source: sev.prnewswire.com

Debate over food irradiation still simmering - Minneapolis Star Tribune
A fter two years of nearly constant food-borne illness outbreaks and recalls of everything from tainted peanut butter to tons of hamburger meat, the Food and Drug Administration's decision this month to allow the irradiation of lettuce and spinach to
Source: www.startribune.com

FDA Extends Consumer Warning on Serrano Peppers from Mexico

noreply@blogger.com (Network) — Sun, 31 Aug 2008 13:00:00 +0000

FDA Extends Consumer Warning on Serrano Peppers from Mexico
Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States.

Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach
In the fight against foodborne illness, FDA is permitting fresh iceberg lettuce and fresh spinach to be irradiated at safe doses.

S and M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Brand Dried Bamboo Fungus Veiled Lady (August 12)
The recall was initiated after routine sampling by New York State Department of Agriculture and Markets food inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in Grove Grow Notes brand Dried Bamboo Fungus Veiled Lady which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites

Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25)
The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE.

Making Sense of Vytorin Concerns
This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications.

FDA Law Enforcers Crack Down on Illegal Botox Scammer
FDA's Office of Criminal Investigations found physicians who put profit before patients when they injected them with fake Botox Cosmetic.

FDA 101: Advisory Committees
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees.

For Tillman, family come first - Chicago Tribune

noreply@blogger.com (Network) — Sun, 31 Aug 2008 01:00:00 +0000

For Tillman, family come first - Chicago Tribune
Charles Tillman was arrested for driving under the influence and faces jail time. Charles Tillman was involved in a domestic dispute. Charles Tillman failed a drug test. Name a rumor and either Tillman or his wife, Jackie, likely read it this summer
Source: www.chicagotribune.com

India Dr Reddy's gets FDA nod for trandolapril tabs - CNBC
MUMBAI, Aug 29 (Reuters) - Indian drugmaker Dr Reddy's Laboratories Ltd has received approval from the U.S. Food and Drug Administration for trandolapril tablets, the regulator's website showed. The drug is a generic version of
Source: www.cnbc.com

Concerns remain as salmonella outbreak comes to an end - Los Angeles Times
Four months after an outbreak of salmonella hospitalized hundreds, forced groceries to toss out of tomatoes and peppers by the thousands, infuriated fruit and vegetable growers and puzzled consumers, health authorities said Thursday that the epidemic
Source: www.latimes.com