TherapeuticsMD (TXMD) Reports FDA Acceptance of Yuvvexy NDA

TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy™ (TX-004HR)

PDUFA target action date of May 7, 2017

BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative womens healthcare company, today announced the acceptance of the NDA for Yuvvexy, the conditionally-approved trade name for TX-004HR, by the U.S. Food and Drug Administration (FDA). Yuvvexy is an investigational bio-identical 17-estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.

The NDA acceptance by the FDA in its 74-day letter indicates... More