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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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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 exclusivity with other ANDA first filers.

Cephalon (acquired by Teva in 2011) sells bendamustine hydrochloride powder for injection, 25 mg and 100 mg (single-dose vial) under brand name Treanda in the US market. Treanda is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma.

Treanda had US sales of approximately $ 133 million for twelve months ending November 2016, according to IMS Health.