US FDA approves Natco Pharma's anti-cancer drug azacitidine

The approved product is a generic version of Vidaza, which recorded annual sales of $ 188 mn

Closures for liquid drugs; Image courtesy: Datwyler
BS B2B Bureau Hyderabad
Last Updated : Jun 27 2017 | 3:39 PM IST
Natco Pharma Limited has received final approval from the US Food and Drug Administration (FDA) for azacitidine injection used in the treatment of cancer. “Natco Pharma Limited is pleased to announce final approval of abbreviated new drug application (ANDA) from the US FDA for azacitidine for injection, 100 mg per vial, single-dose vial - a generic version of Vidaza by Celgene Corporation,” said the company in a press release.

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 $ 188 million for the twelve-month period ending April, 2017, based on industry sales data.

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