LDMP regulatory update

FDA's Reproductive Health Drugs Advisory Committee voted that the overall benefit/risk profiles of 2 compounds do not support approval to treat moderate to severe vasomotor symptoms (VMS) associated with menopause. The committee voted 10-4 against LDMP from the Noven Pharmaceuticals Inc. subsidiary of Hisamitsu. The low-dose paroxetine mesylate has a June 28 PDUFA date. ...