TherapeuticsMD Inc (NASDAQ:TXMD) Reports FDA Acceptance Of New Drug Application And PDUFA Date for TX-001HR

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TherapeuticsMD Inc (NASDAQ:TXMD) reported the NDA acceptance for TX-001HR by the FDA. TX-001HR is the firm’s investigational bio-identical hormone treatment combination of progesterone and estradiol in a single, oral softgel for the cure of moderate-to-grave vasomotor indications due to menopause.

The buzz

The U.S. FDA in its 74-day letter mentioned that the application is adequately complete to allow a substantive assessment and that, at this time, it has not identified any prospective review issues. The FDA stated that the filing review is just a preliminary assessment of the application and is not indicative of insufficiencies that may be noted during the FDA’s evaluation.

Robert G. Finizio, the CEO of TherapeuticsMD, expressed that the NDA acceptance for TX-001HR is another vital milestone for company and reaffirms the commitment and strength of their organization. If permitted, TX-001HR boasts the prospect to be the exclusive combination of bio-identical progesterone and bio-identical estradiol in a single, oral softgel to fulfill the needs of physicians, pharmacies and patients as an FDA-permitted, third-party reimbursed treatment alternative for women struggling with moderate-to-severe vasomotor indications due to menopause.

TX-001HR marks as the firm’s investigational bio-identical hormone treatment combination of progesterone and estradiol in a single, oral softgel for the cure of moderate-to-severe vasomotor indications due to menopause.

Menopause marks as a natural life-stage transition for females with an average start of 51 years. As per United States Census Bureau, around 43 million women in the United States are of menopausal age, 45 years to 64 years. Due to menopause, levels of circulating estrogen drop, often causing vasomotor symptoms such as hot flashes, sleep disturbances and night sweats. VMS affect around 60% to 80% of all menopausal women.


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Menopausal females stand a chance to benefit from hormone therapy, also termed as hormone replacement therapy, which is recognized by major medical societies as the top effective treatment for relief of indications related to menopause.

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