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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: belzutifan
Trade Name: Welireg
Date Designated: 06/24/2020
Orphan Designation: Treatment of von Hippel-Lindau disease
Orphan Designation Status: Designated/Approved
Merck Sharp & Dohme, LLC
126 East Lincoln Ave.
P.O. Box 2000
Rahway, New Jersey 07065
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: belzutifan
Trade Name: Welireg
Marketing Approval Date: 08/13/2021
Approved Labeled Indication: Treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery
Exclusivity End Date: 08/13/2028 
Exclusivity Protected Indication* :  Treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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