BioCentury
ARTICLE | Company News

FDA approves non-hormonal menopause product

June 29, 2013 1:24 AM UTC

FDA approved an NDA for Brisdelle paroxetine from the Noven Pharmaceuticals Inc. subsidiary of Hisamitsu Pharmaceutical Co. Inc. (Tokyo:4530; Osaka:4530) to treat moderate to severe vasomotor symptoms (VMS) -- hot flashes -- associated with menopause. The approval comes despite a 10-4 vote in March by FDA's Reproductive Health Drugs Advisory Committee that the overall benefit/risk profile did not support approval (see BioCentury Extra, March 4). ...