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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
Trade Name: Opdivo
Date Designated: 12/20/2016
Orphan Designation: Treatment of gastric cancer and gastro-esophageal junction cancer
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Company
P. O. Box 5326
Princeton, New Jersey 08543
United States

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

Marketing approved:

1 Generic Name: nivolumab
Trade Name: Opdivo
Marketing Approval Date: 04/16/2021
Approved Labeled Indication: in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
Exclusivity End Date: 04/16/2028 
Exclusivity Protected Indication* :  treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
2 Generic Name: nivolumab
Trade Name: Opdivo
Marketing Approval Date: 05/20/2021
Approved Labeled Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)
Exclusivity End Date: 05/20/2028 
Exclusivity Protected Indication* :  adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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