The first and only FDA-approved bioidentical hormone therapy combination of estradiol and progesterone in a single, oral daily capsule for the treatment of moderate-to-severe vasomotor symptoms, BijuvaTM, from Therapeutics MD is now commercially available in the United States, according to a press release from the company.

Bijuva offers a proven balance of bio-identical estradiol combined with bio-identical progesterone to reduce risk to the endometrium in women with a uterus, according to the release. 
 Bio-identical refers to the estradiol and progesterone that are molecularly identical to the hormones naturally circulating in a woman’s body.

The commercial availability of Bijuva offers an FDA approved alternative to marketed synthetic hormones or individual estrogen and progesterone products that have not been FDA-approved for combination use.  The company intends to leverage its partnerships with compounding pharmacies to meet the growing needs of patients in their community after securing reimbursement, according to the release.

Bijuva, which is available as 1 mg/100 mg strength capsules, carries a Boxed Warning relating to possible dementia, cardiovascular disorders, breast and endometrial cancers.

The hormone therapy combination was granted approval in October, 2018.