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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Itraconazole
Date Designated: 05/19/2016
Orphan Designation: Treatment of basal cell carcinoma nevus syndrome.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Mayne Pharma LLC
1240 Sugg Parkway
Greenville, North Carolina 27834
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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