Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Linezolid Tablets, 600 mg, which is the generic version of Pfizer's Zyvox® 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 in adults and children for the treatment of certain infections caused by susceptible Gram-positive bacteria.
Linezolid Tablets, 600 mg, had U.S. sales of approximately $457.8 million for the 12 months ending Sept. 30, 2015, according to IMS Health.
Currently, Mylan has 269 ANDAs pending FDA approval representing $100.8 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $35.6 billion in annual brand sales, for the 12 months ending June 30, 2015, according to IMS Health.