Mylan Inc. announced the U.S. launch of its Valsartan Tablets USP 40 mg, 80 mg, 160 mg, and 320 mg, which is the generic version of Novartis’ Diovan 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 for the treatment of hypertension, to lower blood pressure.
Valsartan Tablets USP 40 mg, 80 mg, 160 mg, and 320 mg, had U.S. sales of approximately $2 billion for the 12 months ending September 30, 2014, according to IMS Health.
Currently, Mylan has 284 ANDAs pending FDA approval representing $109.2 billion in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.