FDA Reviewing Acomplia Drug
The FDA is set to release results of their review of a weight loss pill called Acomplia which is manufactured by French drug maker Sanofi-Aventis.
The FDA is getting set to release results of their review of a new weight loss drug that is already approved for use in Europe.
Acomplia is the name of the drug which is manufactured by Sanofi-Aventis and on Wednesday of this week, an expert advisory panel is set to meet to discuss the drug.
"With the initial demand for Acomplia likely to be massive, the known neuropsychiatric side effects may make it difficult for the FDA to see a positive risk-benefit ratio," wrote Citigroup analyst Kevin Wilson in a Thursday note.
The decision handed down by the advisory panel may have a big impact on the FDA's final decision. Although they do not have to agree with their expert advisory panels, they often do.
Studies of the Acomplia drug have reported some symptoms such as depression, insomnia and anxiety in patients who take it, thus whether or not the drug will be approved by the FDA is anybody's guess.
Last February, the FDA denied Sanofi's application for their drug to be used as an anti-smoking pill stating that they needed more information before approving it.
Source: http://www.dogflu.ca/06102007/21/fda_reviewing_acomplia_drug» Leave a comment
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