On November 27, 2013 Teva reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for TREANDA through October 2015 for indolent B-cell non-Hodgkin lymphoma (iNHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen (Press release Teva, NOV 27, 2013, View Source;p=irol-newsArticle&ID=1880493 [SID:1234500816]). Orphan status is granted to therapies intended to treat diseases or conditions that affect fewer than 200,000 patients in the United States. With the previously granted six months of pediatric exclusivity for TREANDA, regulatory exclusivity for this indication is now extended through April 2016.

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"Since 2008, TREANDA has played a significant role in the treatment of patients with iNHL that has progressed," said Bill Campbell, Vice President and General Manager, Teva Oncology. "We are pleased the FDA has recognized our commitment to treating patients with this rare form of cancer."

TREANDA is also indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). TREANDA has orphan drug exclusivity for this indication through March 2015. With the previously granted six months of pediatric exclusivity for TREANDA, regulatory exclusivity for this indication lasts until September 20, 2015.

Net sales for Treanda in the United States through the third quarter of 2013 were $531 million.