Natco receives US FDA approval for cancer drug bendamustine

The approved product is generic version of Treanda, which has annual sales of about $ 133 mn in US

Natco Pharma's formulations facility in Kothur

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BS B2B Bureau Hyderabad

Last Updated : Jan 07 2017 | 12:44 PM IST

Natco Pharma Limited has received the final approval for its abbreviated new drug application (ANDA) containing a Paragraph IV certification from the US Food and Drug Administration (FDA) for generic version of bendamustine hydrochloride (HCl) powder for injection - 25 mg and 100 mg (single-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 US market. Natco and Breckenridge filed their ANDA with a Paragraph IV certification on the first-to-file date and expect to share 180-day

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