Tag Archives: Food and Drug Administration

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 [...]
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Mass Gift Ban Repeal Efforts Fizzle

By Reid Paul | Published: August 4, 2010
An effort in the Massachusetts legislature to repeal the state’s ban on many gifts to healthcare providers has failed. The year-old ban is considered one of the most restrictive in the country, banning restaurant meals, various gifts and requiring reporting on transfers of value above $50. “This repeal effort was started by legislators concerned that the [...]
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Merck KGaA MS Drug on the Fast Track

By George Koroneos | Published: July 28, 2010
Merck KGaA received word July 25 that its application for the multiple sclerosis treatment Cladribine had received priority review status by FDA, decreasing the evaluation period from 10 months to six months, and closing the gap between Merck and the competition. “This is a critical milestone on the path to potential approval for short-course therapy with [...]
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Advisory Panel Rejects Avastin For Breast Cancer Treatment

By George Koroneos | Published: July 21, 2010
An FDA advisory panel on Tuesday voted 12–1 to discontinue Avastin (bevacizumab) as a treatment for advanced breast cancer due to post-market studies stating that the treatment does not to increase patient lifespan by any significant length of time. This is a huge problem for Roche who purchased the treatment as part of its merger with [...]
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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 [...]
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