Bijuva to treat hot flashes in US womenJanuary 14, 2019
The US FDA has approved estradiol and progesterone (Bijuva) oral capsules, 1 mg/100 mg, for the treatment of vasomotor symptoms due to menopause in women with a uterus.
The approval is based on the clinical development programme that included the pivotal Phase III Replenish Trial. The results of the trial were published in the journal Obstetrics & Gynecology.
The pill is a novel combination of bio-identical estradiol and progesterone approved for the treatment of vasomotor symptoms associated with menopause in women with a uterus in a once-daily soft gel capsule taken orally.
TherapeuticsMD, a women’s healthcare company which makes the drug, expects Bijuva to be available in the US.