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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Clofazimine
Trade Name: Lamprene
Date Designated: 06/11/1984
Orphan Designation: Treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum.
Orphan Designation Status: Designated/Approved
Novartis Pharmaceutical Corporation
59 Route 10
East Hanover, New Jersey 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Clofazimine
Trade Name: Lamprene
Marketing Approval Date: 12/15/1986
Approved Labeled Indication:
Exclusivity End Date: 12/15/1993 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.