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From the Food and Drug Administration
September 9, 1998

Thalidomide Approved for Erythema Nodosum Leprosum

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Copyright 1998 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1998American Medical Association

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JAMA. 1998;280(10):872. doi:10.1001/jama.280.10.872

The FDA has approved thalidomide (Thalomid, Celgene Corp, Warren, NJ), with unprecedented restrictions on distribution, for the treatment of one form of leprosy—either for acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) or as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. It is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.

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