HERTFORDSHIRE, England, and PITTSBURGH: Mylan N.V. announced the U.S. 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 U.S. 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 U.S. 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 is 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 U.S. – brand-name or generic – is a Mylan product.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high-quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately
50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time.
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.