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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: rapamycin
Date Designated: 02/24/2016
Orphan Designation: Treatment of facial angiofibromas (FA) associated with tuberous sclerosis complex (TSC).
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
AFT Pharmaceuticals Ltd.
129 Hurstmere Road
Level 1, Nielsen Building
Takapuna, Auckland
New Zealand

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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