Posted by Michael Wonder on 09 Mar 2018
TherapeuticsMD announces FDA acceptance of new drug application and Prescription Drug User Fee Act date for TX-001HR
8 March 2018 - No filing review issues identified.
TherapeuticsMD today announced the acceptance of the NDA for TX-001HR by the U.S. FDA. TX-001HR is the company’s investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause.
The FDA in its 74-day letter stated that the application is sufficiently complete to permit a substantive review and that, at this time, the FDA has not identified any potential review issues. The FDA noted that the filing review is only a preliminary evaluation of the application and is not indicative of deficiencies that may be identified during the FDA’s review. The PDUFA target action date for the completion of the FDA's review is 28 October 2018.
