azelaic acid
Drug Details
- Generic Name
- azelaic acid
- Brand Names
- azelaic acid, Azelaic Acid Gel, FINACEA FOAM, AZELEX
- Application Number
- ANDA204637
- Sponsor
- Glenmark Pharmaceuticals Inc., USA
- NDC Codes
- 5
- Dosage Forms
- GEL, AEROSOL, FOAM, CREAM
- Routes
- TOPICAL, CUTANEOUS
- Active Ingredients
- AZELAIC ACID
Indications and Usage
1 INDICATIONS AND USAGE Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. ( 1 ) Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. ( 1 )