DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Food and Drug Administration

Center for Drug Evaluation and Research

Memorandum

Date:	May 1, 2007
From:	Division of Oncology Drug Products Office of Oncology Drug Products/CDER/FDA
To:	Johanna Clifford Executive Secretary, Advisors and Consultants Staff
Subject:	Errata Sheet to FDA Briefing Document for May 9, 2007 ODAC meeting
RE:	NDA 22-062

In reference to the upcoming Oncologic Drugs Advisory Committee meeting, FDA submits the following changes to their briefing package for NDA 22-062, proposed trade name OREC (beclamethasone dipropionate), DOR BioPharma, Inc., proposed indication for the treatment of graft vs. host disease (GvHD) involving the gastrointestinal tract in conjunction with an induction course of high-dose prednisone or prednisolone.

1. Page 11, "Post-hoc analyses," second bullet: "Survival at One Year Post-Randomization" instead of "Survival at One Year Post-Transplant"

2. Page 12, Heading should be "Survival at One Year Post-Randomization" instead of "Survival at One Year Post-Transplant"

3. Page 4, Table, under trial 875, "taper to .125 mg/kg/d" (misplaced decimal point corrected) instead of "taper to 1.25 mg/kg/d"