TherapeuticsMD wins FDA nod for hormone therapy, capping off drugmaker's prolific year
The FDA has approved TherapeuticsMD’s $TXMD hormone therapy for hot flashes associated with menopause, marking the women’s health drugmaker’s third approval this year.
Bijuva, which was approved with a boxed warning of cardiovascular disorders, probable dementia as well as breast and endometrial cancer, is an oral treatment that contains molecularly identical (bio-identical) versions of the hormones estradiol and progesterone for menopausal women with a uterus experiencing moderate-to-severe vasomotor symptoms. The drug will be made available in the second quarter of next year, the company said on Monday.
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