For glioma. NDA 208630, held by Nxdc. Aminolevulinic Acid Hydrochloride.
As of Nov 14, 2026, NDA 208630 (Gleolan), held by Nxdc, was first approved by FDA on Jun 6, 2017, with 4 approved supplements and 0 published complete response letters.
Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan is an 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 6, 2017 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gleolan1.5GM/VIAL · for solution;oral | Aminolevulinic Acid Hydrochloride | RxReference drug |
| Apr 23, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Mar 19, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Aug 22, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Jun 12, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Jun 6, 2017 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
