DOR withdraws EMEA application for orBec
The UK subsidiary of US biopharmaceutical firm DOR BioPharma has had to withdraw its European Marketing Authorization Application for orBec (beclomethasone dipropionate).
In the official notice letter, the firm advised the European Medicines Agency (EMEA) that it could not respond to the latter's request for additional clinical data within the timeframe allocated. The application had originally been submitted in November 2006 for the treatment of gastrointestinal graft-versus-host disease, a common and potentially life-threatening complication of hematopoietic cell transplantation. It was initially designated an orphan medicine in March 2002.
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