Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Fluvastatin Sodium Extended-release Tablets, 80 mg, which is the generic version of Novartis' Lescol XL® Tablets. 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 to reduce elevated total cholesterol, LDL-C, Apo B, and triglyceride, and increase HDL-C in adults with primary hypercholesterolaemia and mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Fluvastatin Sodium Extended-release Tablets, 80 mg, had U.S. sales of approximately $37.6 million for the 12 months ending June 30, 2015, according to IMS Health.
Currently, Mylan has 262 ANDAs pending FDA approval representing $99.3 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.