Teva Gets Orphan Drug Designation for Treanda

New Drug Approvals

 

Teva Announces Additional Regulatory Exclusivity for TREANDA® (Bendamustine HCI) for Injection

Orphan Designation combined with pediatric extension provides regulatory exclusivity through April 2016 for indolent B-cell non-Hodgkin lymphoma indication

JERUSALEM, November 27, 2013 –(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced 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.http://www.pharmalive.com/teva-announces-additional-regulatory-exclusivity-for-treanda

read my old post, contains synthesis

http://newdrugapprovals.wordpress.com/2013/09/19/fda-oks-tevas-injectable-treanda/

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