FDA Approves New Treanda Formulation
The FDA has approved Treanda (bendamustine HCl; Teva) Injection, a new formulation of Treanda for Injection. The new liquid formulation eliminates the need to reconstitute the lyophilized powder with sterile water prior to adding the medicine to the dilutent.
Treanda is an alkylating agent currently approved for use in chronic lymphocytic leukemia (CLL), and indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or rituximab-containing regimen.
Treanda is active against both quiescent and dividing cells. Preclinical studies suggest that Treanda may lead to cell death by a process known as apoptosis as well as by an alternate cell death pathway which disrupts normal cell division known as mitotic catastrophe.
The supplemental New Drug Application (sNDA) for Treanda Injection was submitted on March 8, 2013 and was assigned a Priority Review designation.
For more information call (800) 896-5855 or visit Treanda.com.RELATED: Hematologic Cancers Resource Center