Pafolacianine injection

FDA Drug Profile — Cytalux

Drug Details

Generic Name
Pafolacianine injection
Brand Names
Cytalux
Application Number
NDA214907
Sponsor
On Target Laboratories, Inc.
NDC Codes
1
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
PAFOLACIANINE SODIUM

Indications and Usage

1. INDICATIONS 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. ( 1 )