Teva gains additional regulatory exclusivity for Treanda

Israel-based global generic giant Teva Pharmaceutical Industries (NYSE: TEVA) has granted orphan drug exclusivity by the US Food and Drug Administration for Treanda (bendamustine HCL, for injection) 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.

With the previously granted six months of pediatric exclusivity for Treanda, regulatory exclusivity for this indication is now extended through April 2016, the company said, noting that through the third quarter of 2013 US sales of the drug were $531 million, up from $131 million in full-year 2011. The drug came into Teva’s portfolio with tits $6.8 billion acquisition of Cephalon in 2011.

“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.