India’s drugmaker Natco Pharma has gotten the approval from the U.S. regulator for generic version of Teva’s leukemia treatment Trenda (Bendamustine Hydrochloride powder for Injection).
After getting this clearance, Natco said it plans to launch this drug in the USA on November 1, 2019, or possibly earlier if circumstances should allow. Natco’s marketing partner Breckenridge Pharmaceutical, Inc., will be in charge for the drug in the USA market.
Teva’s subsidiary since 2011, Cephalon, currently sells Bendamustine Hydrochloride powder for Injection under Brand name Trenda in the USA market.
Trenda is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma. Trenda had U.S. sales of approximately $133 Million for twelve months ending November, 2016, according to IMS Health.