Hyderabad: Hyderabad-based drug company Natco Pharma has received final approval from the US health regulator, USFDA, for generic Bendamustine Hydrochloride powder for injection used in treatment of certain types of cancers. The approval has been obtained for abbreviated new drug application (ANDA) containing a paragraph IV certification for generic version of Bendamustine Hydrochloride powder for injection, 25 mg/vial and 100 mg/vial (singe-dose vial), Natco Pharma said in a filing to BSE.
“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 USA market,” the company added.
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, Natco said. Cephalon (acquired by Teva in 2011) sells Bendamustine Hydrochloride powder for injection in the same strengths under brand name Treanda in the US market, it added.
IMS Health shows that Treanda had US sales of approximately $133 million for twelve months ending November 2016, company said. The drug is indicated for the treatment of patients with chronic lymphocytic leukemia and non-Hodgkin’s lymphoma.