The Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for Breckenridge‘s Azacitidine Injection, the generic version of & Celgene‘s Vidaza. Breckenridge submitted the ANDA with its manufacturing partner Natco Pharma Limited and intend to launch the product in the near future.

Vidaza is indicated as treatment for myelodysplastic syndrome (MDS), specifically refractory anemias and chronic myelomonocytic leukemia; it can be given either subcutaneously (SC) or intravenously (IV). Vidaza is a nucleoside cytidine analogue that causes hypomethylation of DNA and thus direct cyotoxicity on abnormal hematopoietic cells in the bone marrow.  

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Vidaza is available as a 100mg strength lyophilized powder for SC injection after reconstitution or IV injection after reconstitution and dilution in single-dose vials.

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