Mylan N.V,a global pharmaceutical company, has announced the US launch of norethindrone acetate and ethinyl estradiol tablets USP, and ferrous fumarate tablets, 1 mg/20 mcg, which is indicated for use by women to prevent pregnancy. Mylan's subsidiary, Mylan Laboratories Limited, received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is a generic version of Allergan's Minastrin 24 FE tablets.
The launch of norethindrone acetate and ethinyl estradiol tablets USP, and ferrous fumarate tablets, 1 mg/20 mcg, further strengthens Mylan's women's healthcare portfolio, one of 10 therapeutic franchise priority areas for the company. From cancer and hypothyroidism, to cardiovascular disease and diabetes, Mylan offers a vast suite of medicines to help women manage a multitude of health conditions.
Norethindrone acetate and ethinyl estradiol tablets USP, and ferrous fumarate tablets, 1 mg/20 mcg, had US sales of approximately $346.9 million for the 12 months ending July 31, 2017, according to QuintilesIMS Health.
Currently, Mylan has 225 ANDAs pending FDA approval representing approximately $101 billion in annual brand sales, according to QuintilesIMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $43.5 billion in annual brand sales, for the 12 months ending December 31, 2016, according to QuintilesIMS Health. Currently, one out of every 13 prescriptions filled in the US - brand-name or generic - is a Mylan product.
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Women over 35 years old who smoke should not use Norethindrone Acetate and Ethinyl Estradiol Tablets USP, and Ferrous Fumarate Tablets, 1 mg/20 mcg. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use.