Teva receives additional regulatory exclusivity for TREANDA from US FDA.
M2 EQUITYBITES-November 28, 2013-Teva receives additional regulatory exclusivity for TREANDA from US FDA(C)2013 M2 COMMUNICATIONS http://www.m2.com
Pharmaceutical company Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced on Wednesday the grant of orphan drug exclusivity for TREANDA by the US Food and Drug Administration (FDA) 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.
Orphan status is granted to therapies intended to treat diseases or conditions that affect fewer than 200,000 patients in the US.
With the previously granted six months of paediatric exclusivity for TREANDA, regulatory exclusivity for this indication is now extended through April 2016.
TREANDA is also indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL). TREANDA has orphan drug exclusivity for this indication through March 2015. With the previously granted six months of paediatric exclusivity for TREANDA, regulatory exclusivity for this indication lasts until 20 September 2015.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Nov 28, 2013|
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