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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pomalidomide
Trade Name: Pomalyst
Date Designated: 01/15/2003
Orphan Designation: Treatment of multiple myeloma
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: pomalidomide
Trade Name: Pomalyst
Marketing Approval Date: 02/08/2013
Approved Labeled Indication: Treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Exclusivity End Date: 02/08/2020 
Exclusivity Protected Indication* :  Treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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