August 2009 - FDA News

FDA Enhances Speed and Transparency of Actions Taken Against Misconduct

FDA Enhances Speed and Transparency of Actions Taken Against Misconduct in Drug and Device Development
The Food and Drug Administration today announced it has stepped up its efforts to prevent non-compliant investigators and others from participating in new product development. FDA s procedures for debarment and disqualification have been enhanced to better protect participants in clinical studies and for ensuring the safety and effectiveness of the medical products marketed to the American public.

FDA Moves Forward on Implementation of Tobacco Law The U.S.

FDA Moves Forward on Implementation of Tobacco Law
The U.S. Food and Drug Administration today announced an action regarding the implementation of the Family Smoking Prevention and Tobacco Control Act. The Agency has officially established the Tobacco Products Scientific Advisory Committee (TPSAC).

FDA Issues Public Health Notification on Glucose Monitoring Technology The

FDA Issues Public Health Notification on Glucose Monitoring Technology
The U.S. Food and Drug Administration (FDA) today advised health care practitioners and patients against using certain glucose monitoring technology that employs a specific test strip when the patients are also receiving therapeutic products containing non-glucose sugars.

Reclaim? DBS? Therapy for OCD What is it? A totally

Reclaim? DBS? Therapy for OCD
What is it? A totally implanted brain stimulator intended to suppress symptoms associated with Obsessive Compulsive Disorder (OCD) that are not adequately controlled with medications and/or other therapies. (Approved: 2/19/2009)

Undeclared Sulfites in Bifeng Nong Fu Shanzhuang Plum Candy New

Undeclared Sulfites in Bifeng Nong Fu Shanzhuang Plum Candy
New York State Agriculture Commissioner Patrick Hooker today alerted consumers that Tiffany Food Corporation, located at 1182 Flushing Ave, Brooklyn, New York is recalling Bifeng Nong fu Shanzhuang plum candy due to the presence of undeclared sulfites. People who have severe sensitivity to sulfites may run the risk of serious or life-threatening reactions if they consume this product.

Nutracoastal Trading LLC Expands Its Voluntary Nationwide Recall Of Steam Dietary Supplement
FOR IMMEDIATE RELEASE - Freeport, NY August 21, 2009 Nutracoastal Trading LLC announced today that it is expanding its July 28th, 2009 voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM.

Van's International Foods Issues Allergy Alert On Undeclared Wheat, Gluten, Milk And Egg In Wheat Free Homestyle Pancakes
Van's International Foods has issued an allergy alert and is voluntarily recalling the following product: 12.4 ounce package of frozen Van's Wheat Free Homestyle Pancakes with the lot number listed below because they contain undeclared wheat, gluten, milk and egg in the product. People who have allergies or sensitivities to wheat, gluten, milk or eggs may run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA Issues Pharmaceutical Industry Guidance on Preventing Melamine Contamination In

FDA Issues Pharmaceutical Industry Guidance on Preventing Melamine Contamination
In a guidance issued today, the U.S. Food and Drug Administration says that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.

FDA Issues Early Communication about Ongoing Safety Review of Weight

FDA Issues Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat
The U.S. Food and Drug Administration announced today that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli.

Sabril Approved by FDA to Treat Spasms in Infants and

Sabril Approved by FDA to Treat Spasms in Infants and Epileptic Seizures
Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures.

REPEL-CV Bioresorbable Adhesion Barrier REPEL-CV Bioresorbable Adhesion Barrier is a

REPEL-CV Bioresorbable Adhesion Barrier
REPEL-CV Bioresorbable Adhesion Barrier is a single use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG). (Approved: 3/6/2009)

Kroger Recalls Super Kids Enriched White Sandwich Bread Due to

Kroger Recalls Super Kids Enriched White Sandwich Bread Due to Undeclared Milk in the Product
CINCINNATI, Ohio, August 21, 2009 The Kroger Co. said today it is recalling Kroger brand Super Kids Enriched White Sandwich Bread sold in 13 states because it may contain milk not listed on the label. Customers should return the product to stores for a refund or replacement.

Limited Recall of 772 Cartons of Iced Jumbo Green Onions due to Possible Health Risk
A precautionary voluntary recall of 772 cartons of iced jumbo green onions under the brand names Omo and Fu Choy distributed from three locations, R.A.M. Produce Distributors of Detroit, Michigan, Franzella Distributing of San Francisco, CA, and United Food Service of East Point, GA has been issued by California-based NewStar Fresh Foods due to the possible presence of Salmonella.

FDA Consumer Health Information Updates The U.S. Food and Drug

FDA Consumer Health Information Updates
The U.S. Food and Drug Administration today released its latest listing of consumer health information updates.

FDA Launches New Center for Tobacco Products The U.S. Food

FDA Launches New Center for Tobacco Products
The U.S. Food and Drug Administration today launched its new Center for Tobacco Products in an historic effort to curb the hundreds of thousands of deaths caused by those products each year.

FDA Approves New Cholesterol-Lowering Drug The U.S. Food and Drug

FDA Approves New Cholesterol-Lowering Drug
The U.S. Food and Drug Administration today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply

Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply
The U.S. Food and Drug Administration today approved Hiberix, a Haemophilus influenzae Type b (Hib) vaccine, as a booster dose for children 15 months through 4 years old. Hiberix is manufactured by GlaxoSmithKline, with U.S. headquarters in Research Triangle Park, N.C. and Philadelphia.

FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug

FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products
The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.

NAVISTAR THERMOCOOL and EZ Steer THERMOCOOL Nav Irrigated Deflectable Diagnostic/Ablation

NAVISTAR THERMOCOOL and EZ Steer THERMOCOOL Nav Irrigated Deflectable Diagnostic/Ablation Catheter for Treatment of Paroxysmal Atrial Fibrillation
The NAVISTAR THERMOCOOL Irrigated Deflectable Diagnostic/Ablation Catheter is used to destroy (ablate) abnormal heart tissue that causes an intermittent abnormal heartbeat in the upper chambers of the heart (paroxysmal atrial fibrillation). (Approved: 2/6/2009)

Hospira Issues Urgent Device Recall For AC Power Cords Hospira,

Hospira Issues Urgent Device Recall For AC Power Cords
Hospira, Inc. (NYSE: HSP), is initiating a nationwide recall of certain Hospira devices that have defective AC power cords manufactured by Electri-Cord Manufacturing Corporation. This recall is being issued in response to customer reports of sparking, charring and fires on the plug of the power cord.

Tanimura & Antle Expands Possible Distribution Area of Voluntary Romaine Recall
Tanimura & Antle, Inc. of Salinas, California is expanding the geographic scope of its voluntary recall of bulk and wrapped romaine head lettuce. Although the volume of cases from the single recalled lot has not changed, the company recognizes the possibility that some customers may have distributed the romaine in states beyond the original 29.

Adams Extract & Spice, LLC Announces Recall Because of Possible Health Risk
Adams Extract and Spice, LLC. is announcing a voluntary recall of products because they have the potential to be contaminated with Salmonella. The products contain a specific lot of ground red pepper supplied by Van de Vries Spice Corporation, 9 Elkins Road, East Brunswick, New Jersey 08816

FDA Issues Final Rules to Help Patients Gain Access to

FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs
The U.S. Food and Drug Administration published two rules today that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don t have other satisfactory treatment options.

FDA Launches New Center for Tobacco Products The U.S. Food

FDA Launches New Center for Tobacco Products
The U.S. Food and Drug Administration today launched its new Center for Tobacco Products in an historic effort to curb the hundreds of thousands of deaths caused by those products each year.

FDA Approves New Cholesterol-Lowering Drug The U.S. Food and Drug

FDA Approves New Cholesterol-Lowering Drug
The U.S. Food and Drug Administration today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.