TherapeuticsMD: FDA OKs Med for Menopause Symptoms

TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women’s healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved BIJUVA™ (estradiol and progesterone) capsules, 1 mg/100 mg, the first and only FDA-approved bio-identical* hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

“The approval of BIJUVA represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms. Menopausal women and their healthcare providers have been seeking bio-identical combination therapies for many years without an FDA-approved option,” said Dr. Brian Bernick, Co-Founder and Director of TherapeuticsMD. “BIJUVA is the first and only FDA-approved combination of bio-identical hormones, offering a proven balance of bio-identical estradiol to reduce moderate to severe hot flashes combined with bio-identical progesterone to reduce the risks to the endometrium.”

“This is an important milestone for TherapeuticsMD as we continue to build towards offering a full portfolio of products to women at all stages of their lives,” said Robert Finizio, TherapeuticsMD CEO and Co-Founder. “BIJUVA addresses a significant demand for bio-identical hormone therapy and provides women, their healthcare providers and pharmacists with a proven bio-identical combination product that can be covered by their insurance.”
https://www.biospace.com/article/releases/therapeuticsmd-announces-fda-approval-of-tx-001hr-bijuva-estradiol-and-progesterone-capsules-for-the-treatment-of-moderate-to-severe-vasomotor-symptoms-due-to-menopause/