Natco Pharma receives final approval for generic Azacitidine for injection for USA market
Hyderabad: Natco Pharma Limited announced that it has got the 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.
Abbreviated New Drug ApplicationAzacitidineAzacitidine injectionBreckenridge PharmaceuticalCelgene CorpFDAfinal approvalgenericInjectionmyelodysplastic syndromeNatco pharmaU.S. Food and Drug AdministrationUSFDAVidaza
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