Lupin gets FDA approval for generic Femhrt

BALTIMORE — Lupin in late December received U.S. Food and Drug Administration approval for its Fyavolv (norethindrone acetate and ethinyl estradiol) tablets, the generic version of Warner Chilcott's Femhrt tablets.

Fyavolv was approved in the .5 mg/0.0025 mg and 1 mg/.005 mg strengths. The medication is indicated for the treatment of moderate to severe vasomotor symptons due to menopause and prevention of postmenopausal osteoporosis.

Lupin said it would begin promoting the product in the United States shortly through its U.S. subsidiary, Lupin Pharmaceuticals.

Femhrt had U.S. sales of $39.9 million for the 12 months ended September 2015, according to IMS.