sinecatechins

FDA Drug Profile — Veregen

Drug Details

Generic Name
sinecatechins
Brand Names
Veregen
Application Number
NDA021902
Sponsor
ANI Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
OINTMENT
Routes
TOPICAL
Active Ingredients
SINECATECHINS

Indications and Usage

1 INDICATIONS AND USAGE Veregen is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older (1.1) . Limitations of Use Safety and effectiveness of Veregen have not been established in immunosuppressed patients, in treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses (1.2) . 1.1 Indication Veregen is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. 1.2 Limitations of Use The safety and effectiveness of Veregen have not been established for treatment beyond 16-weeks or for multiple treatment courses. The safety and effectiveness of Veregen in immunosuppressed patients have not been established.