Posted by Michael Wonder on 29 Oct 2018
TherapeuticsMD announces FDA approval of TX-001HR: Bijuva (oestradiol and progesterone) capsules for the treatment of moderate to severe vasomotor symptoms due to menopause
29 October 2018 - BIJUVA is the first and only FDA approved hormone therapy of bio-identical oestradiol in combination with bio-identical progesterone.
TherapeuticsMD today announced that the United States 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 is based on the Bijuva clinical development program that included the pivotal Phase III Replenish Trial.
