Pharma Focus Asia

TherapeuticsMD Announces Plan to Resubmit the New Drug Application for TX-004HR

Tuesday, November 07, 2017

TherapeuticsMD, Inc., an innovative women’s healthcare company, today announced a regulatory update regarding the New Drug Application (NDA) 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.

On November 3, 2017, the Company participated in an in-person meeting with the Division of Bone, Reproductive, and Urologic Products of the Food and Drug Administration (FDA). At the meeting, the Division agreed to the resubmission of the NDA for TX-004HR without the need for an additional pre-approval study. The Company will commit to conduct a post-approval observational study.

The Company believes it will be in a position to resubmit the NDA for TX-004HR within the coming weeks, with a potential approval of the NDA within two to six months after resubmission, depending on the classification of the review of the NDA.

“We appreciate the hard work and collaborative effort by the FDA in moving TX-004HR one step closer to approval,” said TherapeuticsMD CEO Robert G. Finizio. “We are extremely pleased with the FDA’s position that an additional pre-approval safety study is no longer necessary for the resubmission of the NDA for TX-004HR.”

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