Natco Pharma Receives USFDA’s Final Approval For Generic Azacitidine


Natco Pharma on Tuesday has received final approval of Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (USFDA) for Azacitidine for Injection, 100mg per vial, single-dose vial, a generic version of Vidaza by Celgene Corporation. 

NATCO and its marketing partner Breckenridge Pharmaceutical, Inc. (BPI) plan to launch this product in the US market 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 USD 188 million for the 12-month period ending April, 2017, based on industry sales data.

Natco Pharma Limited is a pharmaceutical company engaged in developing, manufacturing and marketing finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs). 

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