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Natco Pharma receives final approval of ANDA for Azacitidine for Injection

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From USFDA

Natco Pharma has received final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) 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 USA 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 $188 million for the twelve-month period ending April, 2017, based on industry sales data.

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First Published: Jun 27 2017 | 9:22 AM IST

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