Breckenridge Pharmaceutical announces Final ANDA Approval for Azacitidine for Injection

Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA Azacitidine for Injection, 100mg per vial, Single-Dose Vial, a generic version of Vidaza® by Celgene Corporation.   Breckenridge submitted the ANDA with its development and manufacturing partner Natco Pharma Limited.  Breckenridge and Natco intend to launch its ANDA in the near future.

Vidaza® is a prescription anti-cancer chemotherapy drug that is indicated to treat myelodysplastic syndrome (MDS). Vidaza® generated total combined sales of $188 million for the twelve-month period ending April, 2017, based on industry sales data.