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Breckenridge Announces Final ANDA Approval for Azacitidine for Injection

americanpharmaceuticalreviewJune 27, 2017

Tag: Breckenridge , ANDA Approval , Azacitidine

Breckenridge Pharmaceutical announced the 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.

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