Therapeurics eigenaars: slecht nieuws
TherapeuticsMD Enters Into Label Discussions for TX-001HR
BOCA RATON, Fla.--(BUSINESS WIRE)--Sep. 27, 2018-- TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women’s healthcare company, today announced that the Company has entered into discussions with the U.S. Food and Drug Administration (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. As previously announced, 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 October 28, 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.