FDA gives second orphan drug designation to Teva's Treanda

Drug receives designation indolent B-cell non-Hodgkin lymphoma

JERUSALEM — The Food and Drug Administration has designated a drug made by Teva Pharmaceutical Industries as an orphan drug, the company said.

Teva said the drug, Treanda (bendamustine hydrochloride), received the designation for indolent B-cell non-Hodgkins lymphoma through October 2015 that has progressed during or within six months of treatment with a regimen containing Rituxan (rituximab), marketed by Genentech and Biogen Idec. The FDA gives orphan drug designation to treatments for diseases affecting fewer than 200,000 people in the United States.

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

The drug is also used to treat chronic lymphocitic leukemia, for which it also received orphan drug designation through March 2015.


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