TherapeuticsMD Announces Submission of Low Dose BIJUVA 0.5 mg/100 mg Supplemental New Drug Application to FDA

TherapeuticsMD, 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”).

The 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.

“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.

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.

About BIJUVA

BIJUVA 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.

INDICATION

BIJUVA (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.

IMPORTANT SAFETY INFORMATION

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, and PROBABLE DEMENTIA

See full prescribing information for complete boxed warning.

Estrogen Plus Progestin Therapy

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
• The 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)
• The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
• The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Estrogen-Alone Therapy