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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: nivolumab and relatlimab-rmbw
Trade Name: Opdualag
Date Designated: 08/18/2017
Orphan Designation: Treatment of stage IIb to IV melanoma
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Company
P.O. Box 5326
Princeton, New Jersey 08543-5326
United States

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

Marketing approved:

1 Generic Name: nivolumab and relatlimab-rmbw
Trade Name: Opdualag
Marketing Approval Date: 03/18/2022
Approved Labeled Indication: Treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma
Exclusivity End Date: 03/18/2029 
Exclusivity Protected Indication* :  Treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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