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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: budesonide
Trade Name: Eohilia
Date Designated: 12/20/2006
Orphan Designation: Treatment of patients with eosinophilic esophagitis
Orphan Designation Status: Designated/Approved
Takeda Pharmaceuticals U.S.A., Inc.
95 Hayden Avenue
Lexington, Massachusetts 02421
United States

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

Marketing approved:

1 Generic Name: budesonide
Trade Name: Eohilia
Marketing Approval Date: 02/09/2024
Approved Labeled Indication: treatment for 12 weeks in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE)
Exclusivity End Date: 02/09/2031 
Exclusivity Protected Indication* :  treatment of adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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