Blog & Resources Camargo Blog June 3rd, 2013

FDA Rejects Depomed’s Gabapentin for Menopausal Symptoms

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.

Get Our Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our solutions or contact us.

Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.

9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
2505 Meridian Parkway
Suite 150
Durham NC, 27713
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights