FDA Advisory Committee Recommends Approval of Qnexa
The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the review of the New Drug Application that was submitted for Qnexa in October 2011.
U.S. biotech firm VIVUS, Inc. announced Wednesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults.
The Committee voted 20 to 2, on the recommendation for an approval based on a favorable benefit-risk profile.
The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the review of the New Drug Application (NDA) that was submitted for Qnexa in October 2011. The scheduled Prescription Drug User Fee Act (PDUFA) date for Qnexa is April 17, 2012.
"We are pleased with the panel'
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