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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: 04/04/2018
Orphan Designation: Treatment of Kaposi sarcoma
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: 05/14/2020
Approved Labeled Indication: POMALYST (pomalidomide) is indicated for the treatment of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART); and for the treatment of Kaposi sarcoma (KS) in adult patients who are HIV-negative.
Exclusivity End Date: 05/14/2027 
Exclusivity Protected Indication* :  Indicated for the treatment of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART); and for the treatment of Kaposi sarcoma (KS) in adult patients who are HIV-negative.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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