Express Pharma

US FDA approves Natco’s ANDA for generic version of Vidaza


Natco and Breckenridge Pharmaceutical plan to launch the product in the US market

Natco Pharma has got the final approval for Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (FDA) for the generic version of Vidaza (Azacitidine for injection, 100 mg per vial), single-dose vial.

According to a company statement, Natco and its marketing partner Breckenridge Pharmaceutical, Inc. (BPI) plan to launch the product in the US market in the near future.

Vidaza by Celgene Corporation 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 12-month period ended April 2017, based on industry sales data.

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