FDA Advisory Committee rejects low dose mesylate salt of paroxetine for Menopause

Noven Pharmaceuticals, Inc. has announced that the FDA Reproductive Health Drugs Advisory Committee voted 10 to 4 that the overall risk/benefit profile of low-dose mesylate salt of paroxetine (LDMP; 7.5 mg/day) is not acceptable to support approval. LDMP is an investigational nonhormonal treatment specifically developed for moderate to severe vasomotor symptoms (VMS) associated with menopause.