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TherapeuticsMD Announces Submission of New Drug Application Prior Approval Efficacy Supplement to the U.S. Food and Drug Administration for Lower Dose of BIJUVA®
BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, announced today that it submitted a New
About this update from Therapeuticsmd, Inc.
[{"type":"text","content":" BOCA RATON, Fla.--(BUSINESS WIRE)--\nTherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, announced today that it submitted a New Drug Application prior-approval efficacy supplement for BIJUVA 0.5 mg/100 mg (estradiol and progesterone) capsules to the U.S. Food and Drug Administration (FDA) late January 2020.\n\n\nThe submission includes data from the Company’s Phase 3 Replenish Trial for BIJUVA, for which the Company announced results in December 2016, together with additional information and analyses. The Company expects to learn of the acceptance of the efficacy supplement upon receipt of the Filing Review Notification from the FDA, approximately 74 days after the submission of the NDA efficacy supplement. If accepted for review by the FDA, the Company expects that the NDA efficacy supplement will be reviewed under current Prescription Drug User Fee Act timeline goals, within ten months of receipt by the FDA.\n\n\nThe BIJUVA 1 mg/100 mg dose was approved by the FDA in October 2018 and launched commercially in April 2019. 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 (commonly known as hot flashes or flushes) due to menopause in women with a uterus.\n\n\nAbout BIJUVA\n\n\nBIJUVA is a novel combination of bio-identical estradiol and bio-identical progesterone in a once-daily oral softgel capsule. It is approved in the U.S. for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus.\n\n\nINDICATION\n\n\nBIJUVA® is a combination of estradiol and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.\n\n\nIMPORTANT SAFETY INFORMATION\n\n\n\nWARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, and PROBABLE DEMENTIA\n\n\n\nSee full prescribing information for complete boxed warning.\n\n\n\n\n\nEstrogen Plus Progestin Therapy\n\n\n\n\n\n\nEstrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia\n\n\nThe Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial...