FDA concurred with its Advisory Committee’s recommendations and has turned down Depomed’s application seeking a new indication for gabapentin. Depomed has sought approval to use the drug in the treatment of menopausal symptoms – ‘hot flashes’. We reviewed the Advisory Committee’s deliberations in this blog this past April. The drug failed to show superiority over placebo. Depomed issued a press release confirming the news and indicated it would cease all further development efforts for this indication.
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