HERTFORDSHIRE, England and PITTSBURGH, Sept. 8, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg, which is the generic version of Bayer’s Yasmin® Tablets. Mylan’s partner Famy Care Ltd. 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 use by women to prevent pregnancy.(1)
Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg, had U.S. sales of approximately $137.6 million for the 12 months ending June 30, 2015, according to IMS Health. The immediate availability of this product represents Mylan’s thirteenth oral contraceptive launch in the U.S.
Currently, Mylan has 266 ANDAs pending FDA approval representing $99.5 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.
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 around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which nearly 50% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.
(1) Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use and this risk increases with age. Women who use oral contraceptives should be advised to not smoke. Consult your physician prior to beginning oral contraceptive use.
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SOURCE Mylan N.V.
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