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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