Panel Gives Thumbs-Down to Depomed's Hot Flash Drug
The modest reduction in menopause-related vasomotor symptoms (VMS) recorded in three Phase III trials was not sufficient to warrant the side-effect risk associated with gabapentin, according to the FDA's Reproductive Health Drugs Advisory Committee, which voted 12-2 Monday to recommend against Depomed Inc.'s Sefelsa (formerly Serada).
Suite: 1100 | Atlanta, Georgia 30346, USA
Outside of the US
In the U.S. and Canada: +1-800-336-4474
Outside the U.S.: +44-203-684-1796
Hours: Monday - Friday, 8:00am - 6:00 pm EST
Sign up for Highlights FREE e-mail newsletter