FDA Approves TherapeuticsMD’s Bijuva

The FDA granted approval for Bijuva (estradiol and progesterone), TherapeuticsMD’s treatment for moderate to severe hot flash symptoms in women going through menopause.

The combination drug therapy has been approved in 1g/100mg dosage forms and is the first and only agency-approved bioidentical hormone therapy of its kind.

The company expects the hormone therapy to be available in the U.S. in the second quarter of 2019.