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# TherapeuticsMD NDA Under Review for Vasomotor Symptoms
- URL: https://www.fdaweb.com/therapeuticsmd-nda-under-review-for-vasomotor-symptoms/
- Published: 2018-03-08T12:00:00.000Z
- Updated: 2026-09-14T23:28:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140944

FDA has accepted for review a TherapeuticsMD NDA for TX-001HR, an investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for treating moderate-to-severe vasomotor symptoms due to menopause. The agency has set a user fee review action target of 10/28\. The 505(b)(2) NDA submission is based on data from the Phase 3 Replenish Trial, which evaluated the safety and efficacy of four doses of TX-001HR compared to placebo. The co-primary efficacy endpoints in the trial were the change from baseline in the number and severity of hot flashes at weeks 4 and 12 as compared to placebo.