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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Multi-ligand somatostatin analog
Date Designated: 07/27/2004
Orphan Designation: Treatment of patients with functional gastroenteropancreatic (GEP) neuroendocrine tumors (specifically, carcinoid, insulinoma, gastrinoma, somastatinoma, GRFoma, VIPoma and glucagonoma.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 07/20/2017
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Novartis Pharmaceuticals Corporation
One Health Plaza
Office 337 A13.5B
East Hanover, New Jersey 07936
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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