Prescription medicine
Pafolacianine Brand names: Cytalux
Pafolacianine (Cytalux) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the pafolacianine FDA label on DailyMed (effective April 1, 2026, On Target Laboratories, Inc.); the NDA 214907 record on Drugs@FDA; every pafolacianine label on DailyMed.
Highlights of the record
FDA label of April 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer.
Forms and strengths
- 3.2 mg/1.6ml
Injection.
On the market
- Earliest approval on file
- November 29, 2021 Cytalux, On Target Labs; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- November 29, 2035 Cytalux injection; 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
- 58 through July 30, 2026
What is pafolacianine used for?
From the label: indications and usageINDICATIONS AND USAGE CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. CYTALUX is an optical imaging agent indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.
FDA pharmacologic class: Optical Imaging Agent.
Source: FDA drug label (Cytalux), On Target Laboratories, Inc., effective April 1, 2026 (SPL set d21952b9-7c4e-3a56-e053-2a95a90a0ab0), via openFDA; the full label on DailyMed
Is there a generic for pafolacianine (Cytalux)?
No generic pafolacianine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Cytalux injection: the compound patent runs to November 29, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for pafolacianine?
The FDA Adverse Event Reporting System holds 58 reports that list pafolacianine 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 8 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?
- Other optical imaging agents
- the pharmacologic class, with prices and generics
- Pafolacianine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other