CANONSBURG (dpa-AFX) - Generic drugmaker Mylan Inc. (MYL) Wednesday announced the U.S. launch of its Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate, which is the generic version of Warner Chilcott's Loestrin 24 Fe.
Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. THe company has started shipping product.
Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate had U.S. sales of about $24.4 million for the 12 months ending September 30, 2014, according to IMS Health.
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