Tag Archives: Drug

Feds Threaten to Pull ProAmatine for Lack of Postmarket Data (Updated 8/18)

By George Koroneos | Published: August 16, 2010

Image via Wikipedia FDA on Monday announced that it was looking to withdraw approval for the low-blood-pressure treatment midodrine hydrochloride because the companies manufacturing the drug failed to provide data from post-approval studies. The kicker: The drug was approved 14 years ago. FDA gave midodrine hydrochloride—branded by Shire as ProAmatine and produced by a half-dozen generics firms—the green [...]

Posted in FDA | Also tagged Blood pressure, Center for Drug Evaluation and Research, Clinical trial, Food and Drug Administration, Health, Midodrine, pharmaceutical industry, Shire | 1 Comment

Weight-Loss Drug Qnexa Loses in FDA Committee Ruling

By Jeff Schindler | Published: July 16, 2010

Vivus’ Qnexa may help in weight loss, but it also now risks losing its place in the market following FDA’s Advisory Committee’s ruling July 15. The panel of medical experts did not question the effectiveness of the drug, but rather voiced its concerns over safety of the medication. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee [...]

Posted in FDA, Safety | Also tagged Anti-obesity medication, FDA, Fen-phen, Food and Drug Administration, Health, Qnexa, Weight loss | 3 Comments