FDA OKs Tevas Injectable Treanda
FDA Approves Teva's Injectable Treanda
Sept. 17--Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has announced that the US Food and Drug Administration (FDA) has approved a new injectable version Treanda for treatment of indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen, and chronic lymphocytic leukemia.
Teva notes that it has not been established whether Treanda is more effective in treating chronic lymphocytic leukemia than other therapies, except for chlorambucil.
Teva gained Treanda through its acquisition of Cephalon in 2011.
The 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 Prof. Jim Koeller of the University of Texas at Austin.
"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 chronic lymphocytic leukemia or indolent B-cell non-Hodgkin lymphoma that has progressed," said Teva VP and Teva Oncology general manager Bill Campbell.
Posted: September 2013