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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 5-aminolevulinic acid
Date Designated: 11/12/2020
Orphan Designation: Diagnostic for the visualization of tumor tissue in patients undergoing surgical resection for meningioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
NX Development Corp.
870 Corporate Drive
Suite 403
Lexington, Kentucky 40503
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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