Prescription medicine
Hexaminolevulinate Brand names: Cysview
Hexaminolevulinate (Cysview) is a prescription medicine with an FDA approval on record since 2010. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the hexaminolevulinate FDA label on DailyMed (effective June 3, 2026, Photocure Inc.); the NDA 22555 record on Drugs@FDA; every hexaminolevulinate label on DailyMed.
Highlights of the record
FDA label of June 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCYSVIEW 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 [see Warnings and Precautions (5.2
Forms and strengths
Kit.
On the market
- Earliest approval on file
- May 28, 2010 Cysview Kit, Photocure Asa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 4, 2038 Cysview Kit for solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 44 through July 30, 2026
What is hexaminolevulinate used for?
From the label: indications and usageCYSVIEW 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 [see Warnings and Precautions (5.2) ]. […]
Source: FDA drug label (Cysview), Photocure Inc., effective June 3, 2026 (SPL set 5aeed40d-6841-4adf-8940-f51d439fdfa3), via openFDA; the full label on DailyMed
Is there a generic for hexaminolevulinate (Cysview)?
No generic hexaminolevulinate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Cysview Kit for solution, the last expiring on January 4, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2010 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the hexaminolevulinate label say about other medicines?
The hexaminolevulinate label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aminolevulinic acid | contraindications | CONTRAINDICATIONS CYSVIEW is contraindicated in patients with: Porphyria Known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid Porphyria Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives |
Source: FDA drug label (Cysview), Photocure Inc., effective June 3, 2026 (SPL set 5aeed40d-6841-4adf-8940-f51d439fdfa3), via openFDA; the full label on DailyMed
What do FAERS reports show for hexaminolevulinate?
The FDA Adverse Event Reporting System holds 44 reports that list hexaminolevulinate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 2 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Hexaminolevulinate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other