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DOR BioPharma Receives Not Approvable Letter From FDA for orBec(R) for Treatment of Gastrointestinal Graft-vs.-Host Disease
Internet Wire via COMTEX
Oct 19, 2007 8:51:42 AM
DOR Committed to Addressing Unmet Medical Needs of GVHD Patients
EWING, NJ, Oct 19, 2007 (MARKET WIRE via COMTEX News Network) --
DOR BioPharma, Inc. (OTCBB: DORB) ("DOR," or "Company") announced today that it has received a not approvable letter from the US Food and Drug Administration (FDA) for its lead product orBec(R) (oral beclomethasone dipropionate, or oral BDP) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation
The FDA has requested data from additional clinical trials to demonstrate the safety and efficacy of orBec(R). Additionally, the FDA has requested information with respect to other sections of the NDA.
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