Latest headline news from FDA.

Food and Drug Administration Press Releases - Fri, 16 May 2008 13:31:00 GMT
Press releases from FDA http://www.fda.gov en-us Fri, 16 May 2008 13:31:00 GMT tina.gilliam@fda.hhs.gov FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled - Fri, 16 May 2008 13:31:00 GMT
The U.S. Food and Drug Administration today 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.

FDA Takes Action against Cream Cheese Companies, Executives - Thu, 15 May 2008 23:30:00 GMT
The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws.

Manufacturer Removes Remaining Stocks of Trasylol - Wed, 14 May 2008 21:53:00 GMT
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process.

FDA Approves New Formulation of Coagulation Therapy - Fri, 09 May 2008 19:23:00 GMT
he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.

FDA Approves First Generic Ropinirole - Fri, 09 May 2008 15:56:00 GMT
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.

FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products - Thu, 01 May 2008 13:02:00 GMT
The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium.

Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction - Wed, 30 Apr 2008 20:17:00 GMT
Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc.

FDA Embarks on Major Hiring Initiative for its Public Health Mission - Wed, 30 Apr 2008 13:41:00 GMT
The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.

FDA Approves Amitiza for IBS-C - Tue, 29 Apr 2008 22:45:00 GMT
The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over.

Coronary Artery Plaque Imaging Device Cleared by FDA - Tue, 29 Apr 2008 12:42:00 GMT
The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.

FDA Approves Relistor for Opioid-Induced Constipation - Thu, 24 Apr 2008 23:44:00 GMT
The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.

FDA Orders Pet Food Maker to Obtain Emergency Operating Permit - Thu, 24 Apr 2008 22:55:00 GMT
The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog and Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce.

FDA Proposes Recommendations for Two Animal Drug Funding Programs - Thu, 24 Apr 2008 14:04:00 GMT
The U.S. Food and Drug Administration has delivered recommendations to Congress for two programs that provide funding for the review of pioneer and generic animal drugs.

FDA Strengthens Safeguards for Consumers of Beef - Wed, 23 Apr 2008 22:08:00 GMT
The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as "mad cow disease").

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