06 Feb Food And Drug Administration Approves Brand New Libido-Boosting Drug for Premenopausal Females
The usa Food and Drug management (Food And Drug Administration) today authorized bremelanotide (Vyleesi, AMAG Pharmaceuticals), a first-in-class melanocortin 4 receptor agonist for hypoactive sexual interest disorder (HSDD) in premenopausal females.
It joins flibanserin (Addyi, Sprout Pharmaceuticals), the actual only real other FDA-approved HSDD treatment plan for premenopausal ladies.
The Food And Drug Administration had until 23 to complete the review of bremelanotide's new drug application (NDA) under the Prescription Drug User Fee Act (PDUFA) june.
HSDD impacts around 10% of most premenopausal feamales in the usa, or around 6 million ladies, stated Julie Krop, MD, primary medical officer and administrator vice president of medical development and regulatory affairs at AMAG Pharmaceuticals.