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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Exisulind
Date Designated: 02/14/1994
Orphan Designation: For the suppression and control of colonic adenomatous polyps in the inherited disease adenomatous polyposis coli.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
OSI Pharmaceuticals, Inc.
41 Pinelawn Road
Melville, New York 11747
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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