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OrBec FDA Approval Status

FDA Approved: No
Brand name: orBec
Generic name: beclomethasone dipropionate
Company: DOR BioPharma, Inc.
Treatment for: Intestinal Graft-versus-Host Disease (iGVHD)

orBec (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of for the treatment of gastrointestinal graft-versus-host disease.

Development timeline for orBec

DateArticle
Dec  7, 2007DOR BioPharma Announces Results of orBec End of Review Conference with the FDA
Oct 19, 2007DOR BioPharma Receives Not Approvable Letter From FDA for orBec for Treatment of Gastrointestinal Graft-vs.-Host Disease
Jul 19, 2007DOR BioPharma, Inc. Announces 3 Month Extension of FDA PDUFA ActionDate for orBec New Drug Application to Review Supplemental Data
Sep 22, 2006DOR BioPharma Files New Drug Application with FDA to Market orBec for GI GVHD
Jun 30, 2006DOR BioPharma Provides Regulatory Update on orBec
Nov 15, 2005DOR BioPharma Plans FDA NDA and European MAA Filing Strategy for orBec
Apr 20, 2005DOR BioPharma to File NDA for orBec

Further information

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