sinecatechins
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.