BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules 1 mg/20 mcg following the July 20th approval of its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration.

The Amneal product, marketed under the proprietary of taysofy, is an AB-rated generic equivalent for the oral contraceptive brand Taytulla. The drug carries a boxed warning regarding cigarette smoking and serious cardiovascular events and should not be used by women who are over 35 years of age and smoke.

According to IQVIA, U.S. annual sales for Taytulla and its generic equivalents in the 12 months ended June 2021 were approximately $124.4 million.

Taysofy is packaged in cartons containing 5 unit-of-use 28-day blister packs. Each blister pack contains 24 days of active therapy and 4 days of ferrous fumarate supplements.