FDA accepts NDA for bremelanotide a treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women.- Amag Pharma.

AMAG Pharmaceuticals, Inc. announced that the FDA has accepted its New Drug Application (NDA) for bremelanotide, a first-in-class melanocortin 4 receptor agonist designed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the bremelanotide NDA is March 23, 2019. HSDD is the most common type of female sexual dysfunction, affecting approximately six million premenopausal women in the U.S. HSDD is characterized by persistent low sexual desire (or libido) that is associated with distress, often negatively impacting women’s emotional health, intimate relationships, and overall quality of life.