The U.S. Food and Drug Administration (FDA) approved TherapeuticsMD’s oral hormone therapy for menopause symptoms such as hot flashes, sleep disturbances and night sweats, the company said on Monday.
The regulatory nod is the third in five months for the drugmaker, which received approvals for a birth control device and another hormone therapy for menopause symptoms.
The therapy, Bijuva, is an oral softgel capsule containing a combination of artificial hormones chemically identical to human female sex hormones estradiol and progesterone.
TherapeuticsMD expects Bijuva to be available in the United States in the second quarter of 2019.
About 43 million American women are of the menopausal age of between 45 and 64, according to the U.S. Census Bureau. Some 80 percent of all menopausal women experience symptoms like hot flashes and night sweats, the drugmaker said.