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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; nivolumab
Trade Name: OPDIVO; OPDIVO
Date Designated: 09/02/2015
Orphan Designation: Treatment of hepatocellular carcinoma
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; nivolumab
Trade Name: OPDIVO; OPDIVO
Marketing Approval Date: 09/22/2017
Approved Labeled Indication: Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (Indication withdrawn)
Exclusivity End Date: 07/23/2021 
Exclusivity Protected Indication* :  Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (Indication withdrawn)
2 Generic Name: nivolumab; nivolumab
Trade Name: OPDIVO; OPDIVO
Marketing Approval Date: 03/10/2020
Approved Labeled Indication: OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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