FDA approves 'hot flashes' drug Bijuva
The US Food and Drug Administration has approved Bijuva (estradiol and progesterone) capsules, from TherapeuticsMD (Nasdaq: TXMD), the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.
Women’s health specialist TherapeuticsMD expects that Bijuva will be available in the USA in the second quarter of 2019.
Despite what seems to be positive news, the company’s shares fell as much as 10% in afternoon trading on Monday and closed the day down 6.48% at $4.76. The most likely reason for the decline is that Bijuva's approval came with a boxed warning relating to cardiovascular disorders, breast cancer, endometrial cancer, and possible dementia.
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