Skip to main content

Cytalux FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 30, 2021.

FDA Approved: Yes (First approved November 29, 2021)
Brand name: Cytalux
Generic name: pafolacianine
Dosage form: Injection
Company: On Target Laboratories, Inc.
Treatment for: Diagnosis and Investigation

Cytalux (pafolacianine) is a fluorescent imaging agent indicated as an adjunct for the intraoperative identification of malignant lesions in patients with ovarian cancer.

Development timeline for Cytalux

DateArticle
Nov 29, 2021Approval FDA Approves Cytalux (pafolacianine) Injection for Identification of Ovarian Cancer During Surgery
Mar  3, 2021On Target Laboratories Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Pafolacianine Sodium Injection for Identification of Ovarian Cancer During Surgery

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.