Post by icemandios on Apr 11, 2018 16:39:55 GMT
TherapeuticsMD Enters Into Label Negotiations for TX-004HR
BOCA RATON, Fla.
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced that the Company has entered into negotiations with the U.S. Food and Drug Administration (FDA) regarding the proposed label 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 (VVA) 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-004HR is May 29, 2018. The Company does not anticipate providing subsequent updates with respect to label negotiations prior to the PDUFA target action date. There can be no assurance that the FDA will approve the NDA for TX-004HR, or that such approval will occur by the PDUFA target action date, and the entrance into label negotiations does not imply otherwise.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The Company’s late stage clinical pipeline includes two product candidates that have completed phase 3 trials and are awaiting approval by the FDA: TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The Company also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.
BOCA RATON, Fla.
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced that the Company has entered into negotiations with the U.S. Food and Drug Administration (FDA) regarding the proposed label 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 (VVA) 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-004HR is May 29, 2018. The Company does not anticipate providing subsequent updates with respect to label negotiations prior to the PDUFA target action date. There can be no assurance that the FDA will approve the NDA for TX-004HR, or that such approval will occur by the PDUFA target action date, and the entrance into label negotiations does not imply otherwise.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The Company’s late stage clinical pipeline includes two product candidates that have completed phase 3 trials and are awaiting approval by the FDA: TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The Company also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.
