FDA Approves TherapeuticsMD's Low Dose Bijuva

TherapeuticsMD Inc 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. 
• Related Link: TherapeuticsMD, Amneal Settle US Patent Litigation For Bijuva.
• 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.
• Also See: TherapeuticsMD's Birth Control Med Receives FDA Response Letter To Revise Manufacturing Testing Limits.
• Price Action: TXMD shares 14.2% at $0.45 during the premarket session on the last check Tuesday.