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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: avelumab (Recombinant human monoclonal IgG1 antibody against programmed death ligand-1)
Trade Name: Bavencio
Date Designated: 09/21/2015
Orphan Designation: Treatment of merkel cell carcinoma.
Orphan Designation Status: Designated/Approved
EMD Serono Research and Development Institute, Inc.
45A Middlesex Turnpike
Billerica, Massachusetts 01821
United States

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

Marketing approved:

1 Generic Name: avelumab (Recombinant human monoclonal IgG1 antibody against programmed death ligand-1)
Trade Name: Bavencio
Marketing Approval Date: 03/23/2017
Approved Labeled Indication: Treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma
Exclusivity End Date: 03/23/2024 
Exclusivity Protected Indication* :  Treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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