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FDA Approves New Formulation of Coagulation Therapy
submitted by hocket 2 days ago (via fda.gov)
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.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Approves First Generic Ropinirole
submitted by hocket 2 days ago (via fda.gov)
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.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
submitted by hocket 10 days ago (via fda.gov)
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.
 
0 Comments - More Info - Bury   Topic: Food
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Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
submitted by hocket 10 days ago (via fda.gov)
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.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Approves Amitiza for IBS-C
submitted by hocket 11 days ago (via fda.gov)
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.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Embarks on Major Hiring Initiative for its Public Health Mission
submitted by hocket 11 days ago (via fda.gov)
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.
 
0 Comments - More Info - Bury   Topic: Food
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Coronary Artery Plaque Imaging Device Cleared by FDA
submitted by hocket 12 days ago (via fda.gov)
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.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Approves Relistor for Opioid-Induced Constipation
submitted by hocket 14 days ago (via fda.gov)
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.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Orders Pet Food Maker to Obtain Emergency Operating Permit
submitted by hocket 14 days ago (via fda.gov)
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.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Proposes Recommendations for Two Animal Drug Funding Programs
submitted by hocket 14 days ago (via fda.gov)
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.
 
0 Comments - More Info - Bury   Topic: Food





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