Mylan announces U.S. launch of generic Loestrin 24 Fe

Nov 5 2014

Mylan Inc. (Nasdaq: MYL) today 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 (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Mylan has begun shipping product.

Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate had U.S. sales of approximately $24.4 million for the 12 months ending September 30, 2014, according to IMS Health.

Currently, Mylan has 287 ANDAs pending FDA approval representing $112.2 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $29.3 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.