Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has been issued with a Complete Response Letter by the US Food and Drug Administration (FDA) for Treanda.
Teva said that the request concerns a new liquid formation of the currently approved Treanda (bendamustine HCL ) for injection. The company added that the FDA issues Complete Response Letters to request additional information needed to complete the review of applications for product approval.
Teva added, "This Complete Response Letter related to questions regarding stability data and no additional studies are being requested.
Teva said it believes that the requested data is already available and will work with the FDA to expedite this part of the process.
The company added that Treanda remains available and is a safe and an effective treatment for 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.
Published by Globes [online], Israel business news - www.globes-online.com - on July 9, 2013
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