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Teva's TREANDA Injection Gets FDA Approval - Quick Facts

Teva Pharmaceutical Industries Ltd.(TEVA), Tuesday said its TREANDA Injection has been approved by the U.S. Food and Drug Administration or FDA. TREANDA injection is a new formulation of its currently approved TREANDA (bendamustine HCI) for Injection. TREANDA is indicated for use in patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen, and in patients with chronic lymphocytic leukemia or CLL. The efficacy of TREANDA in CLL relative to first line therapies other than chlorambucil has not been established.

This new liquid formulation, whose supplemental New Drug Application was assigned priorirty review by the FDA, removes the step of reconstituting lyophilized powder with sterile water prior to adding the medicine to the dilutent and administering to a patient, Teva said.

"With this new liquid formulation of TREANDA, we are building on the legacy of TREANDA, which has played a valuable role since 2008 in the treatment of patients with CLL or indolent B-cell NHL that has progressed." said Bill Campbell, Vice President and General Manager, Teva Oncology.

by RTTNews Staff Writer

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