Breckenridge announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Bendamustine HCl Powder for IV, the generic version of Cephalon‘s Treanda.
Treanda is an alkylating agent indicated to treat chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. It is a bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring. Mechlorethamine and its derivatives form electrophilic alkyl groups, which then form covalent bonds with electron-rich nucleophilic moieties. The bifunctional covalent linkage can lead to cell death through several pathways.
Bendamustine HCl Powder for IV infusion will be available in 25mg/vial and 100mg/vial strengths. The product is expected to launch in November 2019 or earlier pending certain circumstances.
For more information call (561) 443-3314 or visit bpirx.com.