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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 4-((L-valyl)oxy)butanoic acid
Date Designated: 06/12/2019
Orphan Designation: Treatment of Narcolepsy
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Avadel CNS Pharmaceuticals, LLC
16640 Chesterfield Grove Road, Suite 200
Chesterfield, Missouri 63005
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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