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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: selective inhibitor of mechanistic target of rapamycin complex 1 (mTORC1)
Date Designated: 12/18/2023
Orphan Designation: Treatment of autosomal Dominant Polycystic Kidney Disease (ADPKD)
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Janssen Research & Development, LLC
920 U.S. Highway 202, P.O. Box 300
Raritan, New Jersey 08869
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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