TXMD - TherapeuticsMD seeks FDA approval for low dose BIJUVA

TherapeuticsMD (TXMD) announces that it has submitted a supplemental New Drug Application (“sNDA”) to the FDA for BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg.In approximately 74 days from the submission, the company is expected to learn about the acceptance of the application when it receives Filing Review Notification from the FDA, TherapeuticsMD said in the press release.If accepted, the estimated review time under the Prescription Drug User Fee Act ((PDUFA)) will be within 10 months of the receipt of the application or March 21, 2022.“We believe low-dose BIJUVA will be an important additional therapeutic option for women if approved, and we look forward to bringing it to market,” commented Robert G. Finizio, chief executive officer of TherapeuticsMD.In 2018, FDA approved BIJUVA for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus.

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TherapeuticsMD seeks FDA approval for low dose BIJUVA