Pegulicianine

FDA Drug Profile — LUMISIGHT

Drug Details

Generic Name
Pegulicianine
Brand Names
LUMISIGHT
Application Number
NDA214511
Sponsor
Lumicell, Inc.
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
PEGULICIANINE

Indications and Usage

1 INDICATIONS AND USAGE LUMISIGHT is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. LUMISIGHT is an optical imaging agent indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. ( 1 )