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Natco Pharma receives final approval from USFDA for Azacitidine for injection - The Pharma Times | Pharma & Health Care News Portal
Categories: US FDA Approval

Natco Pharma receives final approval from USFDA for Azacitidine for injection

Mumbai, June 30, 2017: Drug Firm, Natco Pharma said that company 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, company said in afiling with BSE. 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 twelve-month period ending April, 2017, based on industry sales data.

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