HERTFORDSHIRE, England and PITTSBURGH, Sept. 30, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Metformin Hydrochloride Extended-release Tablets USP, 500 mg and 1000 mg, a generic version of Watson's Fortamet®. Mylan 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 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.(1)
Metformin Hydrochloride Extended-release Tablets USP, 500 mg and 1000 mg, had U.S. sales of approximately $770.3 million for the 12 months ending July 31, 2016, according to IMS Health.
Currently, Mylan has 240 ANDAs pending FDA approval representing $98.2 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $34.4 billion in annual brand sales, for the 12 months ending June 30, 2016, 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 more than 2,700 generic and branded pharmaceuticals, 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. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 40,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.
(1) Metformin hydrochloride has been associated with a rare, but serious, metabolic complication called lactic acidosis, which can be fatal. This condition may be associated with other conditions including diabetes mellitus, renal insufficiency, congestive heart failure, tissue hypoperfusion, hypoxemia and advanced age. Patients should contact their healthcare providers with any questions if taking metformin hydrochloride.
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SOURCE Mylan N.V.