TherapeuticsMD Gets FDA OK for Lower Dose of Bijuva Product

By Colin Kellaher

TherapeuticsMD Inc. on Monday said the U.S. Food and Drug Administration approved a 0.5 mg/100 mg dose of the company's Bijuva hormone-therapy.

In a filing with the U.S. Securities and Exchange Commission, the Boca Raton, Fla., pharmaceutical company said it is currently evaluating plans for commercialization of the lower-dose version of the product.

The FDA in late 2018 approved Bijuva, a combination of estradiol and progesterone, in a 1mg/100mg strength for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

01-03-22 0715ET