HERTFORDSHIRE, England and
PITTSBURGH, Sept. 14, 2017 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL), today 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 (1). 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 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
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. Learn more at Mylan.com.
(1) 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.
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SOURCE Mylan N.V.