FDA panel rebuffs two menopause compounds

FDA's Reproductive Health Drugs Advisory Committee voted on Monday that the overall benefit/risk profiles of two compounds do not support approval to treat moderate to severe vasomotor symptoms (VMS) associated with menopause. The committee voted 10-4 against low-dose paroxetine mesylate from the Noven Pharmaceuticals Inc. subsidiary of Hisamitsu Pharmaceutical Co. Inc. (Tokyo:4530; Osaka:4530). Paroxetine mesylate has a June 28 PDUFA date. ...