Skip to Content

OrBec 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 Status and FDA Approval Process 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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide