polidocanol

FDA Drug Profile — Varithena

Drug Details

Generic Name
polidocanol
Brand Names
Varithena
Application Number
NDA205098
Sponsor
Biocompatibles, Inc.
NDC Codes
2
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE Asclera ® (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter. Asclera (polidocanol) is a sclerosing agent indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3mm in diameter. ( 1 )