THALOMID® (thalidomide) is an orally administered drug that was first approved by the FDA in July 1998 for a complication of leprosy (erythema nodosum leprosum). While leprosy is rare in the US, THALOMID® sales grew largely due to widespread use in off-label indications for oncology. In May 2006, the FDA granted the drug approval for multiple myeloma, an indication that physicians had already been treating with the drug on an off-label basis. Celgene, THALOMID’s marketer, estimates that approximately 92% of THALOMID® prescriptions are written for cancer patients.
Other (Erythema nodosum leprosum-ENL)