Posted by Michael Wonder on 27 Nov 2016
TherapeuticsMD announces FDA acceptance of new drug application and PDUFA date for Yuvvexy (TX-004HR)
19 September 2016 - PDUFA target action date of 7 May 2017.
TherapeuticsMD today announced the acceptance of the NDA for Yuvvexy, the conditionally-approved trade name for TX-004HR, by the U.S. FDA. Yuvvexy is an investigational bio-identical 17β-estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy in post-menopausal women.
