Posted by Michael Wonder on 21 Dec 2017
TherapeuticsMD announces FDA acceptance of new drug application and Prescription Drug User Fee Act Date for TX-004HR
20 December 2017 - PDUFA target action date of 29 May 2018.
TherapeuticsMD today announced the acceptance of the resubmission for TX-004HR, the company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy due to menopause, by the U.S. FDA.
The FDA has acknowledged that the resubmission is a complete, class 2 response to the complete response letter received on 5 May 2017 for TX-004HR.
