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TherapeuticsMD Inc (NASDAQ: TXMD) is trading sharply higher after it announced that the FDA approved a low dose version of Bijuva, an oral hormone therapy to treat women with vasomotor symptoms due to menopause.
In a regulatory filing, TherapeuticsMD said that on December 28, the agency cleared its supplemental marketing application for Bijuva, seeking approval for the capsule at the 0.5 mg/100 mg dose level.
The plans to commercialize it are currently under evaluation, the company added.
Bijuva, a hormone therapy combination containing estradiol and progesterone, first gained FDA approval in 2018 at the 1 mg/100 mg dose.
Price Action: TXMD shares 14.2% at $0.45 during the premarket session on the last check Tuesday.
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