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FDA Approves Teva’s TREANDA® (bendamustine HCI) Injection, A New Liquid Formulation

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) approved TREANDA (bendamustine HCI) Injection, a new formulation of the currently approved TREANDA (bendamustine HCI) for Injection. TREANDA 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.

“By eliminating the need for reconstitution, a step is removed making dose preparation fast and convenient for healthcare professionals,” said Jim Koeller, M.S., Professor, University of Texas at Austin, College of Pharmacy.

Teva was assigned a Priority Review designation for the supplemental New Drug Application (sNDA) for the new liquid formulation of TREANDA, which was submitted to the FDA on March 8, 2013. The FDA designates Priority Review for drug applications that would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

“Teva is committed to continuously improving our medicines to deliver greater value to all stakeholders,” said Bill Campbell, Vice President and General Manager, Teva Oncology. “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.”

Indications

TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

TREANDA is indicated for the treatment of 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.

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