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PITTSBURGH — Mylan Inc. has released norethindrone acetate and ethinyl estradiol tablets (1 mg/0.02 mg) and ferrous fumarate, a birth control pill, in the United States.
Mylan said Wednesday that the oral contraceptive product is a generic version of Loestrin 24 Fe from Warner Chilcott.
Mylan has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for the product, indicated for the prevention of pregnancy in women.
Norethindrone acetate and ethinyl estradiol tablets (1 mg/0.02 mg) and ferrous fumarate had U.S. sales of about $24.4 million for the 12 months ended Sept. 30, according to IMS Health data cited by Mylan.
