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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: N-[4-(4-amino-2-ethyl-1H-imidazo[4,5-c]quinolin-1-yl)butyl]methanesulfonamide
Date Designated: 08/13/2004
Orphan Designation: Treatment of stages IIB-IV melanoma
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pfizer, Inc.
50 Pequot
6025-A3106
New London, Connecticut 06320
United States

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

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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