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TherapeuticsMD Announces Submission of Low Dose BIJUVA® 0.5 mg/100 mg Supplemental New Drug Application to FDA
BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, announced today that the Company
About this update from Therapeuticsmd, Inc.
[{"type":"text","content":" BOCA RATON, Fla.--(BUSINESS WIRE)--\nTherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, announced today that the Company submitted a supplemental New Drug Application (“sNDA”) for BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg, to the U.S. Food and Drug Administration (“FDA”).\n\nThe Company expects to learn of the acceptance of the sNDA upon receipt of the Filing Review Notification from the FDA, approximately 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, approximately March 21, 2022.\n\n“We are pleased to have identified a path forward for submission to the FDA of our sNDA for low-dose BIJUVA. 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,” said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD.\n\nBIJUVA 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\nAbout BIJUVA\n\nBIJUVA is a novel combination of bio-identical estradiol and bio-identical progesterone in a once-daily oral softgel capsule. BIJUVA is approved in the U.S. in a 1mg/100mg strength for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus.\n\nINDICATION\n\nBIJUVA (estradiol and progesterone) is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.\n\nIMPORTANT SAFETY INFORMATION\n\nWARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, and PROBABLE DEMENTIA\n\nSee full prescribing information for complete boxed warning.\n\nEstrogen Plus Progestin Therapy\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 infarction (MI)\n\n\nThe WHI estrogen...