NDA Submitted for Low-Dose Paroxetine Mesylate for Menopausal Vasomotor Symptoms
Noven Pharmaceuticals announced that it has submitted a New Drug Application (NDA) for low-dose mesylate salt of paroxetine (LDMP) to the FDA, seeking approval 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 3 studies involving an aggregate of 1,180 subjects from more than 130 centers across the U.S.
LDMP is a non-hormonal treatment option being clinically developed for the treatment of women who suffer from vasomotor symptoms, but who are not candidates for, or who have concerns about, hormone therapy.
For more information call (800) 455-8070 or visit www.noven.com.