hexaminolevulinate hydrochloride

FDA Drug Profile

hexaminolevulinate hydrochloride is listed in the FDA National Drug Code directory with 1 NDC code. Available dosage form: injection, powder, lyophilized, for solution.

Drug Details

Generic Name
hexaminolevulinate hydrochloride
Brand Names
N/A
Application Number
Sponsor
Patheon Italia S.p.A.
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
N/A
Active Ingredients
HEXAMINOLEVULINATE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE CYSVIEW 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) ] . CYSVIEW is an optical imaging agent indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) on the basis of 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. ( 1 , 5.2 )