New Delhi: TherapeuticsMD, Inc. an innovative women’s healthcare company, has recently 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.
“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.”
The approval is based on the BIJUVA clinical development program that included the pivotal Phase III Replenish Trial. The results of the trial were published in the journal Obstetrics & Gynecology.
BIJUVA is a novel combination of bio-identical estradiol and bio-identical progesterone approved for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus in a once-daily softgel capsule taken orally.
TherapeuticsMD expects Bijuva to be available in the United States in the second quarter of 2019. The treatment carries a boxed warning.