Natco Pharma receives final FDA approval for generic Treanda
Natco Pharma has received final approval for the generic version of Bendamustine Hydrochloride powder for injections. The medication is used for the treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma. NATCO plans to launch this drug on November 1, 2019, after settling litigation with Teva over the product. The company expects to share 180 day market exclusivity with other first filers for this generic.
Cephalon (acquired by Teva) sells the product under the brand name Treanda in the US, and had US sales of approximately $133 Million for twelve months ending November 2016, according to IMS Health.