TX 001HR for the treatment of moderate-to-severe vasomotor symptoms due to menopause has PDUFA date of 28 October 2018.- Therapeutics MD

Therapeutics MD, Inc. announced that the Company has entered into discussions with the FDA regarding the proposed label for TX 001HR, 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 Prescription Drug User Fee Act (PDUFA) target action date for the completion of the FDA�s review of the new drug application (NDA) for TX 001HR is 28 October 2018. The Company does not anticipate providing subsequent updates with respect to label discussions prior to the PDUFA target action date. There can be no assurance that the FDA will approve the NDA for TX 001HR, or that such approval will occur by the PDUFA target action date, and the entrance into label discussions does not imply otherwise.