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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: diazoxide choline
Trade Name: Vykat XR
Date Designated: 05/13/2014
Orphan Designation: Treatment of Prader-Willi Syndrome
Orphan Designation Status: Designated/Approved
Soleno Therapeutics, Inc.
1235 Radio Road
Suite 110
Redwood City, California 94065
United States

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

Marketing approved:

1 Generic Name: diazoxide choline
Trade Name: Vykat XR
Marketing Approval Date: 03/26/2025
Approved Labeled Indication: treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS)
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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