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Diet Drug Contrave (Orexigen) Approved By FDA

Diet Drug Contrave (Orexigen) Approved By FDA - A Food and Drug Administration panel voted 13-7 to recommend approval for Orexigen Therapeutics'(OREX_) weight loss drug, Contrave, setting the stage for Contrave to be the first new diet drug approved by the FDA in a decade.

TheStreet's Adam Feuerstein has been live blogging the Orexigen vote, during which the FDA panel decided that the potential benefits outweigh the drug's risks.
>>Orexigen Therapeutics FDA Panel Live Blog
Sales of the weight-loss drug could surpass $1 billion annually if approved by the FDA, according to market estimates. While the FDA doesn't need to follow the recommendation of the expert panel, the FDA often does follow an advisory panel's lead in recommending a drug for approval. A final FDA decision on Orexigen's Contrave is expected by the end of January.

In October, the FDA rejected two diet drugs, Arena Pharmaceuticals'(ARNA_) lorcaserin and Vivus'(VVUS_) Qnexa. Arena's drug was rejected based on cancer risks, and Vivus was asked by the FDA for more information on potential for heart attack.

Shares of Arena and Vivus spiked in the after-hours session on Tuesday after the FDA panel vote on Orexigen.

Diet Drug Contrave (Orexigen) Approved By FDA


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