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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: eflornithine
Trade Name: Iwilfin
Date Designated: 11/22/2017
Orphan Designation: Treatment of neuroblastoma
Orphan Designation Status: Designated/Approved
USWM, LLC
4441 Springdale Rd
Louisville, Kentucky 40241
United States

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

Marketing approved:

1 Generic Name: eflornithine
Trade Name: Iwilfin
Marketing Approval Date: 12/13/2023
Approved Labeled Indication: to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy
Exclusivity End Date: 12/13/2030 
Exclusivity Protected Indication* :  to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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