FDA approval for Teva's leukemia drug Treanda

The US Food and Drug Administration has approved Treanda (bendamustine HCI) Injection from Israeli generics giant Teva Pharmaceutical Industries (NYSE: TEVA).

The approval is for a new formulation of the currently approved Treanda for Injection which is indicated for use in patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen, and in patients with chronic lymphocytic leukemia (CLL).

The efficacy of Treanda in CLL relative to first line therapies other than chlorambucil has not been established. This new liquid formulation removes the step of reconstituting lyophilized powder with sterile water prior to adding the medicine to the dilutent and administering to a patient.