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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: 03/29/2021
Orphan Designation: Treatment of malignant glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Hemerion Therapeutics
12 rue Denis Papin
NEO 2 - Building A
Villeneuve d’Ascq 59650

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

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.