Food and Drug Administration News

Diprivan is a powerful I.V. anesthetic drug used for patients undergoing certain surgeries and diagnostic procedures.

Sepracor Inc. today announced that it has completed the analysis and validation of the preliminary results of a Phase II, 514-patient study evaluating the efficacy and safety of SEP-225289 for the treatment of Major Depressive Disorder, including patients with melancholic and atypical features.

Banning the popular painkillers Percocet and Vicodin, which a U.S. health advisory panel has urged, would not be as drastic as it sounds, some medical experts contend.

Leading interventional pain physicians from key U.S. centers gathered at a special clinical symposium to share their experience with Vertos Medical's mild , the least invasive surgical procedure for treating lumbar spinal stenosis , with no implants left behind.* Their early clinical experiences suggest that mild may be an appropriate treatment ...

The Minneapolis-based Malt-O-Meal Co. is voluntarily recalling certain oatmeal products that contain instant non-fat dry milk suspected of being contaminated with salmonella bacteria.

Patients with atrial fibrillation or atrial flutter soon will have a new treatment option to help improve current management of their disease.

If Vicodin, Percocet banned, what next? UPDATED 2009-07-02 Experts say that if the U.S. Food and Drug Administration chooses to ban Vicodin and Percocet as its advisory panel suggests, the move won't be too drastic because alternatives exist.

Acura Pharmaceuticals Inc. and King Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration issued a Complete Response Letter regarding the new drug application for Acurox Tablets CII, a product intended for the relief of moderate-to-severe pain.

Published: Friday, July 3, 2009 at 5:12 a.m. Last Modified: Friday, July 3, 2009 at 5:12 a.m. The Food and Drug Administration approved a new drug Thursday to treat the heart rhythm disorder known as atrial fibrillation, which affects an estimated 2.5 million people in this country, most of them elderly.

A former surgery technician may have exposed thousands of Colorado patients to hepatitis C when she swapped her own dirty syringes for ones filled with a powerful narcotic, federal authorities said Thursday.

Food distributors across the country announced on Thursday they are recalling nonfat dry milk, cocoa and other products that are linked to a possible salmonella contamination at a Plainview, Minn., milk processor.

A Neuromed employee at work in a company lab. The deal is expected create a stronger pipeline of drugs for CombinatoRx.

A researcher extracts fluid from a vial at the AIDS Vaccine Design and Development Laboratory in New York City.

July 1, 2009 -- Shire plc , the global specialty biopharmaceutical company, today announced results from a Phase 3b study that found VYVANSE CII demonstrated significant efficacy at 14 hours after administration during a simulated workplace environment study in adults with Attention Deficit Hyperactivity Disorder .

Here are some of the latest health and medical news developments, compiled by editors of HealthDay: A sample of Toll House refrigerated cookie dough made at a Nestl USA plant in Virginia has tested positive for E. coli bacteria, the U.S. Food and Drug Administration said Monday.

Discovery Laboratories Inc. said Wednesday the Food and Drug Administration will apply a new standard to the company's respiratory drug candidate application, likely further holding up approval.

Dr. Kathleen Silva, Amag's senior director of quality control, at the company's Cambridge lab last year.

The Food and Drug Administration said Wednesday it is reviewing data on the safety of Lantus, a synthetic insulin made by Sanofi-Aventis SA.

Teva Pharmaceutical Industries Ltd., the Jerusalem drugmaker, said on Wednesday that the U.S. Food and Drug Administration cleared the company to market a generic version of Ortho McNeil Janssen's Ortho Tri-Cyclen Lo oral contraceptive.

Doctors at the Cedars-Sinai Heart Institute announced today the completion of the first procedure in which a patient's own heart tissue was used to grow specialized heart stem cells that were then injected back into the patient's heart in an effort to repair and re-grow healthy muscle in a heart that had been injured by a heart attack.