NDA 22555, held by Photocure Asa. Hexaminolevulinate Hydrochloride.
As of Nov 15, 2026, NDA 22555 (Cysview Kit), held by Photocure Asa, was first approved by FDA on May 28, 2010, with 4 approved supplements and 0 published complete response letters.
CYSVIEW is indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) based on a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.
| Feb 15, 2018 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| May 28, 2010 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cysview Kit100MG/VIAL · for solution;intravesical | Hexaminolevulinate Hydrochloride | RxReference drug |
| Jun 18, 2026 | Supplement 6Labeling · Standard review | Approved | |
| Feb 15, 2018 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jul 29, 2016 | Supplement 4Manufacturing · Priority review | Approved | |
| Nov 28, 2012 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| May 28, 2010 | 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
