Natco Pharma receives USFDA approval for generic Bendamustine HCL Powder

06 Jan 2017 Evaluate

Natco Pharma has received the final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the US Food and Drug Administration (USFDA) for generic version of Bendamustine Hydrochloride powder for Injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial). The pharma major and its marketing partner Breckenridge Pharmaceutical, Inc., plans to launch this drug in the USA market on November 1, 2019.

Cephalon (acquired by Teva in 2011) sells Bendamustine Hydrochloride powder for Injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial) under brand name TREANDA in the USA market. TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma. TREANDA had U.S. sales of approximately $133 Million for twelve months ending November, 2016 as per IMS Health.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.

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