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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: eltrombopag
Trade Name: Promacta
Date Designated: 11/08/2013
Orphan Designation: Treatment of aplastic anemia
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corp.
One Health Plaza
East Hanover, New Jersey 07936
United States

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

Marketing approved:

1 Generic Name: eltrombopag
Trade Name: Promacta
Marketing Approval Date: 08/26/2014
Approved Labeled Indication: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
Exclusivity End Date: 08/26/2021 
Exclusivity Protected Indication* :  Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
2 Generic Name: eltrombopag
Trade Name: Promacta
Marketing Approval Date: 11/16/2018
Approved Labeled Indication: PROMACTA is indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
Exclusivity End Date: 11/16/2025 
Exclusivity Protected Indication* :  PROMACTA is indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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