Mumbai: Natco Pharma on Friday said it has received the USFDA approval to manufacture a drug for injections used in the treatement of chronic lymphocytic leukemia (CLL) and non-Hodgkins lymphoma.
"We are pleased to announce the final approval of Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (USFDA) for generic version of Bendamustine Hydrochloride powder for injection," Natco Pharma said in a BSE filing here.
Natco plans to launch this drug on November 1, 2019, or earlier, through its marketing partner Breckenridge Pharmaceutical Inc, in the US market, it said.
Currently, US-based Cephalon Inc sells Bendamustine Hydrochloride powder for injection under the brand name Treanda, which is indicated for the treatment of patients with CLL and non-Hodgkin's lymphoma.
Treanda had US sales of approximately $133 million for 12 months ending November 2016, according to IMS Health.