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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mepolizumab
Trade Name: NUCALA®
Date Designated: 05/28/2004
Orphan Designation: For treatment of hypereosinophilic syndrome
Orphan Designation Status: Designated/Approved
GlaxoSmithKline LLC
1250 S. Collegeville Road
Collegeville, Pennsylvania 19426
United States

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

Marketing approved:

1 Generic Name: mepolizumab
Trade Name: NUCALA®
Marketing Approval Date: 09/25/2020
Approved Labeled Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause
Exclusivity End Date: 09/25/2027 
Exclusivity Protected Indication* :  treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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