Mylan N.V. announced the US launch of norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg (chewable), which is the generic version of Warner Chilcott's Generess Fe tablets.
Mylan's partner Famy Care Ltd. received final approval from the US 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's immediate shipment of norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg (chewable) represents the company's ninth oral contraceptive product launch in the US.
Norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg (chewable) had US sales of approximately $114.7 million for the 12 months ending December 31, 2014, according to IMS Health.
Currently, Mylan has 269 ANDAs pending FDA approval representing $104.1 billion in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $27.3 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.