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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Hydrocortisone
Trade Name: ALKINDI® SPRINKLE
Date Designated: 05/13/2015
Orphan Designation: Treatment of pediatric adrenal insufficiency (0 through 16 years of age).
Orphan Designation Status: Designated/Approved
Eton Pharmaceuticals, Inc.
21925 West Field Parkway, Suite 235
Deer Park, Illinois 60010
United States

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

Marketing approved:

1 Generic Name: Hydrocortisone
Trade Name: ALKINDI® SPRINKLE
Marketing Approval Date: 09/29/2020
Approved Labeled Indication: ALKINDI® SPRINKLE is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency
Exclusivity End Date: TBD  
2 Generic Name: hydrocortisone
Trade Name: Khindivi
Marketing Approval Date: 05/28/2025
Approved Labeled Indication: replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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