Search Orphan Drug Designations and Approvals
-
| 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 | ||||||||||||||||
| Sponsor: |
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 | |
-
