The united states Food and Drug Administration (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), really the only other HSDD that is FDA-approved treatment premenopausal ladies.
The Food And Drug Administration had until June 23 to accomplish the writeup on bremelanotide’s brand new medication application (NDA) beneath the approved Drug consumer Fee Act (PDUFA).
HSDD impacts about 10% of most premenopausal feamales in the usa, or around 6 million ladies, stated Julie Krop, MD, primary officer that is medical administrator vice president of medical development and regulatory affairs at AMAG Pharmaceuticals. ادامه خواندن “Food And Drug Administration Approves Brand Brand New Libido-Boosting Drug for Premenopausal Ladies”