On June 2, 2016 Mylan N.V. (NASDAQ, TASE: MYL) reported the U.S. launch of Azacitidine for Injection, 100 mg/vial, which is a generic version of Celgene’s Vidaza Injection, 100 mg/vial. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product (Press release, Mylan, JUN 2, 2016, View Source [SID:1234512966]). Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of the five French-American-British (FAB) subtypes of myelodysplastic syndrome, a blood cell disorder that can occur as a result of cancer treatments or can progress to leukemia.

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Mylan
Azacitidine for Injection, 100 mg/vial, had U.S. sales of approximately $236.3 million for the 12 months ending March 31, 2016, according to IMS Health.
Mylan’s launch of this product adds to the company’s portfolio of more than 150 injectable products available to patients in the U.S. across a broad array of therapeutic categories. Azacitidine for Injection is also a part of a growing U.S. portfolio of more than 20 oncology medications that includes treatments for breast, lung, colorectal, ovarian and hematologic cancers.
Currently, Mylan has 254 ANDAs pending FDA approval representing $108.3 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.