Regulatory Affairs Syndicator

Teva Pharmaceutical Industries said on Wednesday it received tentative approval from the Food and Drug Administration to sell its 5 milligram and 10 milligram capsules of Zaleplon, a generic short-term treatment for insomnia.

TORONTO (CP) - Labopharm Inc. stock hit a 20-month high Wednesday after it announced the U.S. Food and Drug Administration no longer requires it to do an additional clinical study of its once-daily version of the painkiller tramadol.

Older mental health drugs risky for elderlyReuters AlertNet, UK - 23 minutes ago… The Food and Drug Administration warned in April that newer "atypical" anti-psychotic medicines such as Johnson & Johnson's Risperdal and El…

A drug used to increase a woman’s chances of becoming pregnant may cause birth defects and miscarriages, according to a safety alert issued this week by Canadian health regulators.

UPDATE 1-US FDA warns about Genzyme drug in MS trialReuters - 13 hours agoWASHINGTON, Nov 30 (Reuters) - The US Food and Drug Administration issued a health alert on Wednesday over the use of Genzyme Corp. …

PRESS RELEASE - November 29, 2005, Abuja, Nigeria — The Voice of America (VOA), which broadcasts in Hausa and English to listeners across Nigeria, has organized a workshop for Nigerian journalists to explore the issue of drug resistance and its impact on diseases such as malaria, tuberculosis, and HIV/AIDS.

Shares of Inspire Pharmaceuticals Inc. surged Wednesday away from its 52-week low, the day before the Food and Drug Administration is due to rule on the company’s dry eye treatment.

Nov. 29, 2005 - The U.S. Food and Drug Administration (FDA) yesterday announced that MBI Distributing, Inc. (MBI) has agreed to cease manufacturing and distributing drugs until it corrects manufacturing deficiencies.

American Pharmaceutical Partners Inc. said Wednesday that the Food and Drug Administration granted approval for the drug maker to market a generic version of Pfizer Inc.’s antibiotic Unasyn.

LEVERKUSEN, Germany (AFX) - Bayer AG’’s HealthCare unit said the US Food and Drug Administration (FDA) has approved its once-daily oral antibiotic drug Avelox for the treatment of complicated intra-abdominal infections, or stomach infections.

SALEM, Ore.—-Nov. 30, 2005–Not all snack food companies are hustling to meet the January 2006 Food and Drug Administration deadline that forces the inclusion of trans fat content on nutrition labeling.

Drug dispensing errors closer to eradicationIn-PharmaTechnologist.com, France - 48 minutes ago… drug being dispensed, then compares the information with a drug ID library, and confirms quality compliance with Food and Drug Administration (F…

J&J Asks FDA to OK Schizophrenia DrugMSN Money - 1 hour agoThe new drug application with the Food and Drug Administration covers Paliperidone extended-release tablets, a once-daily oral medication. …

WESTON, Fla.—-Nov. 30, 2005–Apotex Corp. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for ofloxacin otic, 0.3%.

LEXINGTON, Mass. & RAMAT GAN, Israel—-Nov. 30, 2005–Predix Pharmaceuticals, a drug discovery and development company, announced today that under the Special Protocol Assessment process, it has reached final agreement with the United States Food and Drug Administration on the design and statistical analysis plan of its first pivotal study for PRX-00023, its 5-HT1A agonist and lead product