TherapeuticsMD submits a New Drug Application to the FDA for BIJUVA®

TherapeuticsMD, Inc., an inventive pharmaceutical company that focuses on women healthcare, has recently announced that it has presented a New Drug Application (NDA) pre-approval efficacy supplement to the U.S. FDA (Food and Drug Administration) for BIJUVA 0.5 mg/100 mg tablets.

Reportedly, the submission consists of data from the firm’s Phase 3 Replenish study for BIJUVA, for which the pharma had published results in December 2016, along with analyses and additional information.

According to reliable sources, TherapeuticsMD anticipates learning of the approval of the efficacy supplement upon acceptance of the Filing Review Notification from the FDA, after nearly 74 days of the NDA efficacy supplement submission.

After being picked for review, the firm believes that the drug application efficacy supplement would be evaluated within present Prescription Drug User Fee Act timeline objectives, under ten months of receipt by the FDA.

The BIJUVA 1 mg/100 mg dose was previously approved in October 2018 by the FDA and was commercially launched in April 2019. It marks as the only bio-identical hormone treatment combination of progesterone and estradiol in an oral, single capsule to be approved by the FDA.

Evidently, it is mostly consumed once-a-day in order to treat severe to moderate vasomotor symptoms (also known as flushes or hot flashes) caused due to menopause in women.

Prior to this news, TherapeuticsMD had made a revolutionary announcement when it revealed that its women’s health products will now be available for patients through the PlushCare platform, a virtual healthcare service that allows patients to reserve a virtual doctor’s appointment.

Speaking on the move, Dawn Halkuff, Chief Commercial Officer, TherapeuticsMD, said that they are that women now have an alternative to buy their products through the PlushCare virtual care solution. This service offers a convenient option for women to consult with a doctor to receive a credible treatment option for reproductive and menopausal conditions.

Source Credit: https://ir.therapeuticsmd.com/news-releases/news-release-details/therapeuticsmd-announces-submission-new-drug-application-prior