Noven Pharma files low-dose mesylate salt of paroxetine for Menopause

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., has submitted to the FDA a New Drug Application (NDA) seeking approval to market low-dose mesylate salt of paroxetine (LDMP) for the treatment of vasomotor symptoms associated with menopause. In March 2012, Noven announced completion of the LDMP clinical development program, which included two Phase III studies involving an aggregate of 1,180 subjects from more than 130 centers across the U.S. Phase III study results for LDMP are scheduled to be presented at the North American Menopause Society Annual Meeting in October 2012