Thalidomide has been approved by the FDA for ENL and MM in combination with dexamethasone. EMA has also approved it to treat MM in combination with prednisone and/or melphalan. Orphan indications by the FDA include graft-versus-host disease, mycobacterial infection, recurrent aphthous ulcers, severe recurrent aphthous stomatitis, primary brain malignancies, AIDS-associated wasting syndrome, Crohns disease, Kaposis sarcoma, myelodysplastic syndrome and hematopoietic stem cell transplantation.