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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
Trade Name: Gleolan
Date Designated: 01/15/2013
Orphan Designation: Visualization of malignant tissue during surgery for malignant glioma (WHO grades III and IV)
Orphan Designation Status: Designated/Approved
NX Development Corporation
1827 South Bayshore Lane
Miami, Florida 33133
United States

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

Marketing approved:

1 Generic Name: 5-aminolevulinic acid
Trade Name: Gleolan
Marketing Approval Date: 06/06/2017
Approved Labeled Indication: Optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery
Exclusivity End Date: 06/06/2024 
Exclusivity Protected Indication* :  Optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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