The US Food and Drug Administration (FDA) has granted orphan drug status for Teva Pharmaceutical's Treanda 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 the indication is now extended through April 2016.
Teva vice president and general manager of Oncology Bill Campbell said, "Since 2008, TREANDA has played a significant role in the treatment of patients with iNHL that has progressed."
The drug, which has orphan drug status for this indication through March 2015, is also indicated for the treatment of patients with chronic lymphocytic leukemia (CLL).
With the previously granted six months of pediatric exclusivity for the drug, regulatory exclusivity for the indication lasts until 20 September 2015.
The company said that net sales for Treanda in the US through the third quarter of 2013 were $531m.
The drug is also indicated for the treatment of 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.
