Reversal reaction and erythema nodosum leprosum
are two reactional episodes that can occur in leprosy patients at any time during the disease.
The FDA's announcement Monday came just two weeks after a panel of outside scientific advisers voted 8-2 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.
THALOMID received FDA clearance in 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum
(ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.
7), leprosy was associated with erythema nodosum leprosum
This applicant is seeking authorization to market a generic version of thalidomide 100 mg and 50 mg tablets in the United States for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum