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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: 07/14/2011
Orphan Designation: Treatment of Churg-Strauss Syndrome
Orphan Designation Status: Designated/Approved
GlaxoSmithKline LLC
Corporation Service Company
1250 S. Collegeville Rd.
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: 12/12/2017
Approved Labeled Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)
Exclusivity End Date: 12/12/2024 
Exclusivity Protected Indication* :  Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)
2 Generic Name: mepolizumab
Trade Name: NUCALA
Marketing Approval Date: 06/06/2019
Approved Labeled Indication: NUCALA prefilled autoinjector and single syringe device is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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