June 28, 2008Wrinkle Relief: Injectable Cosmetic Fillers Wrinkle Relief: Injectable Cosmetic Fillers
Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5)
Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. Did tomatoes cause Salmonella outbreak? - Daily Independent Did tomatoes cause Salmonella outbreak? - Daily Independent
WASHINGTON — As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak - or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested Source: www.dailyindependent.com House committee criticizes FDA over bonuses - Salon Jun 26th, 2008 | WASHINGTON -- A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Source: www.salon.com Baxter weighs whether to sell heparin vials again in U.S. market - Chicago Tribune Baxter weighs whether to sell heparin vials again in U.S. market - Chicago Tribune
Baxter International Inc. Chairman and Chief Executive Robert Parkinson is leaving open the possibility that the company may stay out of the business of selling vials of heparin in the U.S. market. The company recalled vials of the popular blood Source: www.chicagotribune.com House committee says FDA bonuses should go to inspectors, not highest - Minneapolis Star Tribune WASHINGTON - A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee Source: www.startribune.com Did tomatoes cause Salmonella outbreak? - Daily Independent WASHINGTON — As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak - or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested Source: www.dailyindependent.com Could Korean Leader Learn from Controversies over U.S. Beef Imports? - BusinessWeek At first blush, a delay in South Korea’s resumption of U.S. beef imports in the face of vociferous public protests may appear yet another instance of emotional nationalism in the way of a deal, which makes business sense. But although it certainly Source: www.businessweek.com Gay Blood Donors - WOKR 13 (Rochester, N.Y.) - Giving blood is one of the most honorable deeds a person can do. Claire Broomfiled feels it's her responsibility. “I’ve got something that someone else needs, and I'm happy to share it if I can do so,” she said. However, not Source: www.13wham.com Western Growers Asks for Congressional AG Committee Hearings Regarding - Forbes IRVINE, Calif., June 28 /PRNewswire-USNewswire/ -- Western Growers is urging the House Committee on Agriculture to hold hearings as soon as possible on the salmonella outbreak that has been associated with fresh, red round, roma and plum tomatoes Source: www.forbes.com Committee critical of FDA bonuses - Salon Jun 26th, 2008 | WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the Source: www.salon.com House committee criticizes FDA over bonuses - Salon Jun 26th, 2008 | WASHINGTON -- A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Source: www.salon.com Amgen osteoporosis drug could face FDA scrutiny - Forbes Amgen osteoporosis drug could face FDA scrutiny - Forbes
Amgen 's experimental osteoporosis drug denosumab could have difficulty gaining Food and Drug Administration approval in its initial try, due to a higher incidence of infections compared with placebo seen in some patients, according to an Source: www.forbes.com Could Korean Leader Learn from Controversies over U.S. Beef Imports? - BusinessWeek At first blush, a delay in South Korea’s resumption of U.S. beef imports in the face of vociferous public protests may appear yet another instance of emotional nationalism in the way of a deal, which makes business sense. But although it certainly Source: www.businessweek.com Committee critical of FDA bonuses - Seattle Post Intelligencer WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday Source: seattlepi.nwsource.com UPDATE 2-UCB plans epilepsy drug launch in autumn, shares up - Reuters UK BRUSSELS, June 27 (Reuters) - Shares in UCB SA (UCB.BR: Quote , Profile , Research ) jumped on Friday after the Belgian pharmaceutical group said it aimed to launch its new epilepsy drug Vimpat in the autumn following European Medicines Agency Source: uk.reuters.com FDA Boosts Bonuses Despite Ongoing Criticism From Hill - Washington Post Resize Text The Food and Drug Administration increased bonuses to its employees by 29 percent in the past year, despite earlier objections from lawmakers. The FDA paid $35 million in staff incentives for the year ending April 12, up from $27.1 Source: www.washingtonpost.com House committee criticizes FDA over bonuses - BusinessWeek A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee. Lawmakers were Source: www.businessweek.com Vanda falls as insomnia drug misses some goals - Forbes While biotechnology company Vanda Pharmaceuticals Inc. said Thursday a late-stage trial for an insomnia drug met its goal, the drug failed to show a long-term benefit compared with placebo, sending shares tumbling. In afternoon trading, Vanda shares Source: www.forbes.com Death-linked obesity drug - Sunday Herald AN ANTI-OBESITY drug implicated in the deaths of five people is being handed out to Scots in contravention of advice from medical authorities. Rimonabant - also known under the brand name Accomplia - has just been given the go-ahead for general use Source: www.sundayherald.com Tomatoes Return to Stores, Menus as California Begins Harvest - AG Weekly Tomatoes Return to Stores, Menus as California Begins Harvest - AG Weekly
FRESNO, Calif. (BUSINESS WIRE) - Just in time for the start of tomato harvest in major California production areas, restaurants and grocery stores are announcing the return of tomatoes to store shelves and menus. The move comes in light of Source: www.agweekly.com Cause of salmonella outbreak still not pinned down - Seattle Times Cause of salmonella outbreak still not pinned down - Seattle Times
WASHINGTON — As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak — or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested Source: seattletimes.nwsource.com UPDATE 1-UCB wins EU green light for epilepsy drug - CNBC LONDON, June 26 (Reuters) - The European Medicines Agency has recommended approval of UCB's Tomatoes may be absolved - Traverse City Record-Eagle Tomatoes may be absolved - Traverse City Record-Eagle
WASHINGTON (AP) -- As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak -- or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested Source: www.record-eagle.com Akorn-Strides gets FDA OKs for famotidine injection - CNBC BOSTON (Thomson Financial) - Akorn-Strides LLC, a joint venture of Akorn Inc. and Strides Arcolab Ltd., said Thursday it received Food and Drug Administration approval for its famotidine injection. The Buffalo Grove, Ill.-based therapeutic Source: www.cnbc.com Committee critical of FDA bonuses - Seattle Post Intelligencer WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday Source: seattlepi.nwsource.com FDA Incentive Pay Jumps To $35 Million in 2007 - Wall Street Journal WASHINGTON -- The U.S. Food and Drug Administration awarded employees more than $35 million in incentive pay for fiscal year 2007, a 29% jump from the previous year despite cries from Congress that the agency's bonuses to senior officials are Source: online.wsj.com Tomato 'repacking' vexes salmonella trackers - San Francisco Gate A widespread practice of mixing tomatoes from different farms at produce distribution centers has made it impossible so far to trace the source of a nationwide salmonella outbreak that has sickened hundreds, federal regulators said Friday. Dr. David Source: www.sfgate.com House committee criticizes FDA over bonuses - Boston Globe WASHINGTON— A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee Source: www.boston.com AspenBio Pharma Commences FDA Clinical Trial for AppyScore(TM - MSN MoneyCentral AspenBio Pharma, Inc. (NASDAQ: APPY) an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, has officially initiated a clinical trial to support the FDA 510(k) application for the Source: news.moneycentral.msn.com Committee critical of FDA bonuses - Forbes A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday said some Source: www.forbes.com Cause of salmonella outbreak still not pinned down - Seattle Times WASHINGTON — As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak — or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested Source: seattletimes.nwsource.com Amgen osteoporosis drug could face FDA scrutiny - CNN Money NEW YORK (Associated Press) - Amgen's experimental osteoporosis drug denosumab could have difficulty gaining Food and Drug Administration approval in its initial try, due to a higher incidence of infections compared with placebo seen in some patients Source: money.cnn.com Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28)
Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. Investigation goes beyond tomatoes - Baltimore Sun Investigation goes beyond tomatoes - Baltimore Sun
WASHINGTON - Investigators probing the Salmonella saintpaul outbreak that has sickened at least 810 Americans, including 25 in Maryland, are trying to make sure that tomatoes are the cause, an official of the Centers for Disease Control and Source: www.baltimoresun.com Feds question if tomatoes are to blame - Modesto Bee Police shoot, kill man who stomped baby to death Modesto man sentenced to a year in jail in son's death Modesto police lose suspect, kill pit bulls in his yard Ban on gay marriage needs non-religious basis Child's beating death 'too horrific' to Source: www.modbee.com Committee critical of FDA bonuses - Seattle Post Intelligencer WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday Source: seattlepi.nwsource.com Amgen osteoporosis drug could face FDA scrutiny - Forbes Amgen osteoporosis drug could face FDA scrutiny - Forbes
Amgen 's experimental osteoporosis drug denosumab could have difficulty gaining Food and Drug Administration approval in its initial try, due to a higher incidence of infections compared with placebo seen in some patients, according to an Source: www.forbes.com Tomatoes not alone on FDA's radar - Detroit Free Press WASHINGTON -- As salmonella cases continue to climb, the government is investigating whether tainted tomatoes really are to blame for the record outbreak -- or if the problem is with another ingredient or a warehouse that is contaminating newly Source: www.freep.com Critics blast feds' legal shields for manufacturers - Chicago Tribune WASHINGTON — Bridget Robb's 6-year-old daughter watched fearfully one morning last December as her mother nearly passed out in pain. A wire that connected a defibrillator in Robb's chest had broken, causing it to send waves of powerful electric Source: www.chicagotribune.com AspenBio Pharma Commences FDA Clinical Trial for AppyScore(TM - MSN MoneyCentral AspenBio Pharma, Inc. (NASDAQ: APPY) an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, has officially initiated a clinical trial to support the FDA 510(k) application for the Source: news.moneycentral.msn.com Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)
Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13) ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16) The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. Recalls and Safety Alerts: FDA Studying Potential Safety Issues with Several Drugs FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information... Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. June 27, 2008FDA Approves Diaphragm-Pacing Device FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. FDA Takes Action against Seafood Processing Company, Executives The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. Red Tomato Warning Expanded Nationwide The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Recall of Nestle Pure Life Purified Water (June 24) This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions US checks if tomatoes caused Salmonella outbreak - Forbes US checks if tomatoes caused Salmonella outbreak - Forbes
As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak - or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested tomatoes. The Source: www.forbes.com Barr Pharmaceuticals spent $1.7M lobbying in 1Q - Forbes Generic drug maker Barr Pharmaceuticals Inc. spent nearly $1.7 million in the first quarter lobbying on legislation affecting the drug industry, according to a recent disclosure form. The Montvale, N.J.-based company lobbied on several bills related Source: www.forbes.com Committee critical of FDA bonuses - Seattle Post Intelligencer WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday Source: seattlepi.nwsource.com Centocor seeks OK for new arthritis drug - Philadelphia Business Journal Centocor Inc. filed a biologics license application with the Food and Drug Administration Friday seeking approval for its new drug candidate golimumab as a treatment for three conditions: rheumatoid arthritis, psoriatic arthritis and ankylosing Source: philadelphia.bizjournals.com Health Winners & Losers: Exelixis - Street.Com Health stocks closed out the week on a bright note, outperforming the broader markets Friday and airing scattered business, regulatory and clinical news. Exelixis EXEL and GlaxoSmithKline GSK said early Friday that they will not extend their cancer Source: www.thestreet.com Painkiller Deemed Dangerous by Advocacy Group - HULIQ.com Some painkillers may do more harm than good. Public Citizen, a consumer advocacy group, is pushing the U.S. Food and Drug Administration (FDA) to ban a prescription painkiller chemically known as propoxyphene, citing the dangerous risks it poses to Source: www.huliq.com U.S. tomato-linked salmonella illnesses surpass 800 - Reuters WASHINGTON (Reuters) - The number of people sickened in a salmonella outbreak linked to certain tomatoes has topped 800 as U.S. investigators continue to try to pinpoint the source of the contamination. The U.S. Centers for Disease Control and Source: www.reuters.com Barr shares rise on Mirapex patent case victory - MSN MoneyCentral NEW YORK (AP) - Shares of Barr Pharmaceuticals Inc. rose Friday as a Delaware federal court invalidated several patents covering Boehringer Ingelheim Pharmaceuticals Inc.'s Mirapex, opening the door for a generic launch. Barr shares rose $1.15, or 2 Source: news.moneycentral.msn.com Foodservice group spent $172,442 lobbying in 1Q - CNBC WASHINGTON - The International Foodservice Distributors Association spent $172,442 in the first quarter to lobby an increase in the minimum wage, agriculture and energy legislation, and other issues. The trade group, whose members include Sysco Corp Source: www.cnbc.com UPDATE 2-Merck, Schering end combo respiratory drug bid - Reuters NEW YORK, June 27 (Reuters) - Merck & Co Inc (MRK.N: Quote , Profile , Research , Stock Buzz ) and Schering-Plough Corp (SGP.N: Quote , Profile , Research , Stock Buzz ) said on Friday they withdrew their U.S. application for combining their Source: www.reuters.com FDA 101: How to Use the Consumer Complaint System and MedWatch FDA 101: How to Use the Consumer Complaint System and MedWatch
When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of four lamb feed products, packaged in 50-pound bags, due to the potential for higher than acceptable levels of copper. On National HIV Testing Day Chembio Reports Completion of Pediatric - MSN MoneyCentral On National HIV Testing Day Chembio Reports Completion of Pediatric - MSN MoneyCentral
Chembio Diagnostics, Inc. (OTCBB: CEMI) ("Chembio" or the "Company") reported today, National HIV Testing Day, that it has completed a clinical study designed to evaluate the performance of its two FDA (United States Food & Drug Administration Source: news.moneycentral.msn.com Centocor, Inc. Submits BLA to FDA for Golimumab in the Treatment of - Phramalive.com Extensive Clinical Development Program Investigating Golimumab in the Treatment of These Diseases Serves as Basis for the Application HORSHAM, Pa., June 27, 2008 /PRNewswire/ -- Centocor, Inc. announced today that a Biologics License Application (BLA Source: www.pharmalive.com House committee criticizes FDA over bonuses - BusinessWeek A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee. Lawmakers were Source: www.businessweek.com Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection.
Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) FDA investigating TNF blockers and cancer risk in children and young adults. Drug Shortage: MVI Adult Injectable Hospira information updated. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. February 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Recalls and Safety Alerts: Avoid Using ReadyMED Infusion Pumps with Cubicin In an April 4, 2008 letter, Cubist Pharmaceuticals advised healthcare professionals not to use the drug Cubicin with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health. Cubicin (daptomycin for injection) is an antibiotic used to tre... June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. UPDATE 2-Merck, Schering end combo respiratory drug bid - Reuters UPDATE 2-Merck, Schering end combo respiratory drug bid - Reuters
NEW YORK, June 27 (Reuters) - Merck & Co Inc (MRK.N: Quote , Profile , Research , Stock Buzz ) and Schering-Plough Corp (SGP.N: Quote , Profile , Research , Stock Buzz ) said on Friday they withdrew their U.S. application for combining their Source: www.reuters.com Merck, Schering end combo respiratory drug bid - Guardian Unlimited NEW YORK, June 27 (Reuters) - Merck & Co Inc and Schering-Plough Corp said on Friday they withdrew their U.S. application for combining their blockbuster allergy drugs Singulair and Claritin into one pill, and ended an eight-year joint effort on the Source: www.guardian.co.uk UPDATE 2-UCB plans epilepsy drug launch in autumn, shares up - Reuters BRUSSELS, June 27 (Reuters) - Shares in UCB SA (UCB.BR: Quote , Profile , Research , Stock Buzz ) jumped on Friday after the Belgian pharmaceutical group said it aimed to launch its new epilepsy drug Vimpat in the autumn following European Medicines Source: www.reuters.com FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial CDC: Salmonella-Tainted Tomato Illnesses Rise to 756 - FOX News CDC: Salmonella-Tainted Tomato Illnesses Rise to 756 - FOX News
That's roughly 200 more illnesses than health officials had counted a week ago, in what has become the nation's largest-ever outbreak of salmonella from tomatoes. The continuing rise in cases is due mostly to state laboratories finishing backlogs of Source: www.foxnews.com Aethlon Medical Featured in Medical Device Daily - MSN MoneyCentral Aethlon Medical is the developer of the Hemopurifier ® , a first-in-class medical device designed to treat infectious disease. The Hemopurifier ® provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles, and Source: news.moneycentral.msn.com FDA Boosts Bonuses Despite Ongoing Criticism From Hill - Washington Post Resize Text The Food and Drug Administration increased bonuses to its employees by 29 percent in the past year, despite earlier objections from lawmakers. The FDA paid $35 million in staff incentives for the year ending April 12, up from $27.1 Source: www.washingtonpost.com 'Trust Drug' Oxytocin Unbelievable For Now - ABC News 'Trust Drug' Oxytocin Unbelievable For Now - ABC News
Normally, this would not be a problem. Zak, a professor of economics and the founding director of the Center for Neuroeconomics Studies at Claremont Graduate University in Claremont, Calif., is generally happy to talk about his research, which Source: www.abcnews.go.com PanGenex (PGXC) Releases Shareholder and Operational Update - Forbes PanGenex Corporation (Pink Sheets: PGXC), a publicly traded company, pursues business opportunities in the $70 billion dollar nutraceutical and dietary supplement industry. With a focus on the cardiovascular health segment, PanGenex develops and Source: www.forbes.com Ranbaxy Gains Tentative Approval to Manufacture and Market - Forbes PRINCETON, N.J., June 25 /PRNewswire/ -- Ranbaxy Laboratories Limited (RLL), announced today that the company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Valganciclovir Hydrochloride Tablets Source: www.forbes.com FDA: Merck can't market Gardasil to women 27-45 - Newsday NEWARK, N.J. - Drug maker Merck says the Food and Drug Administration has rejected expanding the use of cervical cancer vaccine Gardasil to include women ages 27 to 45. The agency cited "issues that preclude approval" within the expected review Source: www.newsday.com House committee criticizes FDA over bonuses - Boston Globe WASHINGTON— A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee Source: www.boston.com Medicines hopeful on drug patent extension - MSN MoneyCentral NEW YORK (AP) - Drug developer Medicines Co. could gain a patent extension on its blood thinner product Angiomax, following a measure by the House of Representatives earlier this week. In a Securities and Exchange Commission filing Tuesday, the Source: moneycentral.msn.com UPDATE 3-UCB to launch epilepsy drug in autumn, shares up - Reuters BRUSSELS, June 27 (Reuters) - Shares in UCB SA (UCB.BR: Quote , Profile , Research , Stock Buzz ) jumped on Friday as the Belgian pharmaceutical group said it aimed to launch its new epilepsy drug Vimpat in the autumn, after winning a green light Source: www.reuters.com Quark Pharmaceuticals Receives FDA Approval of IND for Kidney - Forbes FREMONT, Calif., June 25 /PRNewswire/ -- Quark Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for its siRNA drug candidate, DGFi, in kidney Source: www.forbes.com Vaccine help for kids on the way - Chicago Sun-Times ATLANTA -- A federal advisory panel on Thursday endorsed two new combination vaccines designed to reduce the number of needle sticks that young children must endure to get the recommended immunizations. The panel gave its nod to a four-in-one shot Source: www.suntimes.com June 26, 2008Albuterol Inhalers: Time to Transition Albuterol Inhalers: Time to Transition
Manufacturers have been directed to phase out albuterol inhalers that use chlorofluorocarbons (CFCs)--propellants that deplete the ozone layer. Here are facts about switching to alternative inhalers that use hydrofluoroalkane (HFA) propellants. Red Tomato Warning Expanded Nationwide The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes. Spring 2008 Drug Safety Newsletter DSN provides information for healthcare professionals and the medical community about findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new molecular entities. June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Warning on Certain Types of Raw Red Tomatoes FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. GlaxoSmithKline says FDA approves KINRIX combination vaccine for - CNBC GlaxoSmithKline says FDA approves KINRIX combination vaccine for - CNBC
PHILADELPHIA (Thomson Financial) - GlaxoSmithKline said the U.S. Food and Drug Administration (FDA) has approved KINRIX, a combination vaccine for children against diphtheria, tetanus, pertussis and polio diseases. Clinical studies of KINRIX have Source: www.cnbc.com FDA OKs GlaxoSmithKline kids' combination vaccine - CNBC PHILADELPHIA - GlaxoSmithKline PLC said Wednesday it won Food and Drug Administration approval for a combination vaccine to protect children against diphtheria, tetanus, pertussis and polio. Glaxo said the vaccine, Kinrix, is the first to combine Source: www.cnbc.com Salmonella outbreak illnesses rise to 756 - Reuters WASHINGTON (Reuters) - More than 750 people have become ill in an outbreak of Salmonella linked to certain types of tomatoes, U.S food safety officials said on Thursday. The U.S. Centers for Disease Control and Prevention said 756 people in 34 states Source: www.reuters.com Merck Gets Dealt FDA Setback On Gardasil Marketing - CNN Money Merck & Co. (MRK) ran into a rare roadblock for its blockbuster cervical- cancer vaccine Gardasil when the Food and Drug Administration put off a decision on allowing sales to older women. The FDA denied the pharmaceutical giant's supplemental Source: money.cnn.com FDA won't clear expanded Merck cancer vaccine use - Reuters NEW YORK (Reuters) - U.S. regulators did not approve Merck & Co's application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women within an expected review period, the drugmaker said on Wednesday. Merck had applied Source: www.reuters.com GlaxoSmithKline says FDA approves KINRIX combination vaccine for - Forbes PHILADELPHIA (Thomson Financial) - GlaxoSmithKline said the U.S. Food and Drug Administration (FDA) has approved KINRIX, a combination vaccine for children against diphtheria, tetanus, pertussis and polio diseases. Clinical studies of KINRIX have Source: www.forbes.com Committee critical of FDA bonuses - Seattle Post Intelligencer WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday Source: seattlepi.nwsource.com FDA blocks expanded indication for Merck's Gardasil - Boston Globe WHITEHOUSE STATION, N.J.— Merck & Co. said Wednesday the Food and Drug Administration rejected expanding the use of cervical cancer vaccine Gardasil to include women ages 27 to 45, citing "issues that preclude approval" within the expected review Source: www.boston.com The FDA's Latest Victim - Motley Fool The FDA just can't seem to approve anything these days. Earlier in the week, the agency delayed Eli Lilly 's (NYSE: LLY ) heart drug, prasugrel. Now, Merck (NYSE: MRK ) says it'll have to wait for a label change to its already-approved human Source: www.fool.com FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Morphine Sulfate 60 mg Extended Release Tablets Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Spring 2008 Drug Safety Newsletter DSN provides information for healthcare professionals and the medical community about findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new molecular entities. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. FDA Announces New Labeling Changes for Regranex The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01 percent (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. CDC Survey Shows a Decade of Progress in Reducing High School Smoking - Forbes CDC Survey Shows a Decade of Progress in Reducing High School Smoking - Forbes
WASHINGTON, June 26 /PRNewswire-USNewswire/ -- The latest survey of high school smoking rates, released today by the U.S. Centers for Disease Control and Prevention (CDC), shows that while the nation has made remarkable progress in reducing youth Source: www.forbes.com United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16) Medicis announced that the company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg. Pregnant Women to Benefit from Better Information A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Morphine Sulfate 60 mg Extended Release Tablets Morphine Sulfate 60 mg Extended Release Tablets
Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Albuterol Inhalers: Time to Transition Manufacturers have been directed to phase out albuterol inhalers that use chlorofluorocarbons (CFCs)--propellants that deplete the ozone layer. Here are facts about switching to alternative inhalers that use hydrofluoroalkane (HFA) propellants. Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. GE Healthcare Tells FDA Panel Heart Imaging Agents Are Safe - CNN Money GE Healthcare Tells FDA Panel Heart Imaging Agents Are Safe - CNN Money
SILVER SPRING, Md. -(Dow Jones)- Medical companies, including GE Healthcare, and doctors on Tuesday told a U.S. Food and Drug Administration panel ultrasound heart-imaging agents are safe. Heart-imaging agents, or contrasting agents, remain a concern Source: money.cnn.com Tainted tomato cases soar - Atlanta Journal Constitution The number of Americans sickened by salmonella-contaminated tomatoes has soared to 707, making it the largest outbreak connected to the crop since the Centers for Disease Control and Prevention started keeping records in the 1960s. The actual number Source: www.ajc.com CDC Immunization Advisory Committee Recommends Two New Pediatric - Earthtimes -- GSK's ROTARIX(R) [Rotavirus Vaccine, Live, Oral] recommended for routine vaccination of infants to protect against rotavirus gastroenteritis (RGE) -- ROTARIX, approved by the FDA on April 3, 2008 , is the only rotavirus vaccine that offers Source: www.earthtimes.org FDA Takes Heat on Employee Bonuses - Wall Street Journal In 2004, Congress expanded a government bonus system to help stem the flow of skilled government workers heading for higher-paid jobs in the private sector. Now, at least one congressman is questioning the FDA’s use of the money. Figures released Source: blogs.wsj.com FDA delays decision on Eli Lilly blood clot drug - Forbes Eli Lilly shares hit a new 52-week low Tuesday, a day after the company announced the Food and Drug Administration needed three more months to review its blood thinner drug. The FDA did not ask for new clinical trials, but company spokeswoman Tammy Source: www.forbes.com The latest safety tips on eating tomatoes - Newsday The latest safety tips on eating tomatoes - Newsday
Avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that the Food and Drug Administration has cleared of suspicion. Check the Web site www.fda.gov for an updated list. Also safe are grape tomatoes Source: www.newsday.com Salmonella can ride water into tomatoes - Monterey County Herald Mark Roh, U.S. Food and Drug Administration's acting regional director holds a bag of tomatoes being tested for salmonella bacteria at FDA's southwest regional research lab in Irvine. WASHINGTON — Pick a tomato in the blazing sun and plunge it Source: www.montereyherald.com Sirion Therapeutics Announces FDA Approval of Durezol(TM) for - PR Newswire TAMPA, Fla., June 24 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Durezol(TM Source: sev.prnewswire.com FDA delays decision on Eli Lilly blood clot drug - Forbes Eli Lilly shares hit a new 52-week low Tuesday, a day after the company announced the Food and Drug Administration needed three more months to review its blood thinner drug. The FDA did not ask for new clinical trials, but company spokeswoman Tammy Source: www.forbes.com Ranbaxy gets U.S. FDA approval to make, market Valganciclovir HCI - Forbes MUMBAI (Thomson Financial) - India's Ranbaxy Laboratories Ltd. said it received approval from the United States Food and Drug Administration to manufacture and market Valganciclovir HCI tablets, used in the treatment of cytomegalovirus (CMV Source: www.forbes.com Briefs: Nokia Buys Software Maker; Detroit Newspapers Offering Buyouts - The Ledger Nokia Corp. is buying the consortium that makes the software for its phones and making it available for free to other manufacturers, in hopes of blunting the influence of competing software providers. Nokia said Tuesday that it is offering to buy the Source: www.theledger.com Water In Tomatoes Can Be A Breeding Ground for Salmonella - Redorbit.com As the Food and Drug Administration investigates a national salmonella outbreak, researchers are finding the farm isn't the only place tomatoes are contaminated. Something as simple as washing a tomato can make it susceptible to both bacteria and Source: www.redorbit.com FDA delays decision on Eli Lilly blood clot drug - NWI.com INDIANAPOLIS - Eli Lilly shares hit a new 52-week low Tuesday, a day after the company announced the Food and Drug Administration needed three more months to review its blood thinner drug. The FDA did not ask for new clinical trials, but company Source: www.thetimesonline.com GlaxoSmithKline says FDA approves KINRIX combination vaccine for - Forbes GlaxoSmithKline says FDA approves KINRIX combination vaccine for - Forbes
PHILADELPHIA (Thomson Financial) - GlaxoSmithKline said the U.S. Food and Drug Administration (FDA) has approved KINRIX, a combination vaccine for children against diphtheria, tetanus, pertussis and polio diseases. Clinical studies of KINRIX have Source: www.forbes.com FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Enforcement Actions for Food Safety Violations In separate enforcement actions, FDA shuts down companies for food safety violations. These actions include a recall of certain smoked seafood products. FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Tumor Necrosis Factor (TN |
