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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: everolimus ointment
Date Designated: 09/10/2015
Orphan Designation: Topical treatment of Tuberous Sclerosis Complex-related skin lesions
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Aucta Pharmaceuticals, LLC
675 US Highway One
North Brunswick, New Jersey 08902
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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