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DOR submits orBec NDA for GVHD

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

DOR BioPharma announced Sept. 22 its submission of its oral beclomethasone product orBec for treatment of gastrointestinal Graft-versus-Host disease. The Miami-based company reported in November 2005 that the orBec submission was slated for early 2006 (1Pharmaceutical Approvals Monthly December 2005, In Brief). orBec is a two-pill system "designed to specifically target and treat upper and lower GI GVHD with reduced systemic immunosuppressive side effects," DOR explained. The firm noted that orBec has a fast-track designation and may qualify for a priority review; if granted such a review, the product could reach the market by March 2007. DOR also said it is preparing a European submission for November...

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