TherapeuticsMD Submits Low Dose BIJUVA SNDA To FDA

(RTTNews) - TherapeuticsMD Inc. (TXMD) said Tuesday that it submitted a supplemental New Drug Application or "sNDA" for BIJUVA or estradiol and progesterone capsules, 0.5 mg/100 mg, to the U.S. Food and Drug Administration.

The company expects to learn of the acceptance of the sNDA upon receipt of the Filing Review Notification from the FDA, about 74 days after submission. If accepted, the company expects that the review time under the Prescription Drug User Fee Act (PDUFA) will be within ten months of receipt by the FDA, about March 21, 2022.

BIJUVA is the only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule. It is taken once-daily for the treatment of moderate to severe vasomotor symptoms, which is commonly known as hot flashes or flushes, due to menopause in women with a uterus.