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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pembrolizumab
Date Designated: 06/06/2026
Orphan Designation: treatment of neuroendocrine prostate cancer (NEPC)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Merck, Sharp & Dohme LLC.
126 E. 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.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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