Natco Pharma Limited Receives Final Approval for Generic Bendamustine HCL POWDER for USA market
January 06, 2017 at 07:21 am
Natco Pharma Limited announced the final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the U.S. Food and Drug Administration (FDA) for generic version of Bendamustine Hydrochloride powder for Injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial). Pursuant to the settlement of the Paragraph IV litigation, NATCO plans to launch this drug on November 1, 2019, or earlier under certain circumstances, through its marketing partner Breckenridge Pharmaceutical Inc., in the USA market.