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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
Trade Name: KEYTRUDA
Date Designated: 12/30/2015
Orphan Designation: Treatment of Hodgkin lymphoma.
Orphan Designation Status: Designated/Approved
Merck Sharp & Dohme LLC
126 East Lincoln Ave.
P.O. Box 2000
Rathway, Pennsylvania 07065
United States

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

Marketing approved:

1 Generic Name: pembrolizumab
Trade Name: KEYTRUDA
Marketing Approval Date: 03/14/2017
Approved Labeled Indication: Treatment for adult and pediatric patients with refractory classical Hodgkin Lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy.
Exclusivity End Date: 03/14/2024 
Exclusivity Protected Indication* :  Treatment of adult and pediatric patients with refractory classical Hodgkin Lymphoma, or who have relapsed after 3 or more prior lines of therapy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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