Mylan N.V. announced 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.
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.
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.
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.
