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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: lenalidomide
Trade Name: Revlimid
Date Designated: 01/04/2017
Orphan Designation: Treatment of splenic marginal zone lymphoma
Orphan Designation Status: Designated/Approved
Celgene Corporation
86 Morris Avenue
Summit, New Jersey 07901
United States

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

Marketing approved:

1 Generic Name: lenalidomide
Trade Name: Revlimid
Marketing Approval Date: 05/28/2019
Approved Labeled Indication: REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).
Exclusivity End Date: 05/28/2026 
Exclusivity Protected Indication* :  In combination with a rituximab product for the treatment of adult patients with previously treated splenic marginal zone lymphoma
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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