Mylan (MYL) Announces U.S. Launch of Generic Fortamet Tabs

September 30, 2016 9:51 AM EDT

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Mylan N.V. (Nasdaq: MYL) 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.



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