Friday, May 10, 2013

FDA advisers vote against approval for Depomed's menopause drug

March 4 (Reuters) - Advisers to the U.S. Food and Drug Administration on Monday recommended the agency reject a drug made by Depomed Inc to reduce the frequency and severity of hot flashes associated with menopause.

The panel of advisers voted 12-2 against the drug, Sefelsa, which is a long-acting version of the epilepsy drug gabapentin. The panel concluded that the drug's modest efficacy did not outweigh the side effects.

(Reporting By Toni Clarke; Editing by Gerald E. McCormick)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: MENOPAUSE DEPOMED/


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