In a review posted to its Web site Tuesday, The FDA said Qnexa was effective in helping obese patients shed pounds, but the agency raised questions about the drug's safety.
The experts sitting on the FDA's Endocrinologic and Metabolic Drugs Advisory Committee will weigh data and testimony from Vivus and the FDA before voting on whether to recommend Qnexa for approval. The FDA is not required to follow the recommendation of its advisory panels, but most often it does.
Vivus is trying to become the first company in more than a decade to gain U.S. approval for a new weight-loss drug. Two other companies -- Arena Pharmaceuticals (ARNA) and Orexigen Therapeutics (OREX) -- are fast on its heels.Vivus' Qnexa consists of two currently approved drugs: The generic weight-loss drug phentermine and topirimate, a drug used to treat epilepsy and migraine, marketed as Topomax by Johnson & Johnson (JNJ). -- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.
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