The FDA's announcement on Monday came just two weeks after a panel of outside scientific advisers voted 8 to 2 to recommend that the agency approve the drug for patients with erythema nodosum leprosum, or ENL, a complication of leprosy that causes skin lesions, fever and other symptoms.
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The FDA panel is in the second day of its consideration of the thalidomide drug made by Warren New Jersey-based Celgene, for use in a skin condition called erythema nodosum leprosum, or ENL . A rare complication of leprosy, ENL causes painful nodules which can cause infection, scarring or skin ulcers.