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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: 09/15/2015
Orphan Designation: Treatment of small cell lung cancer.
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Company
5 Research Parkway
Wallingford, Connecticut 06492
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: 08/16/2018
Approved Labeled Indication: For the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. (Indication withdrawn)
Exclusivity End Date: 12/29/2020 
Exclusivity Protected Indication* :  For the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. (Indication withdrawn)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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