aminolevulinic acid hydrochloride
Drug Details
- Generic Name
- aminolevulinic acid hydrochloride
- Brand Names
- AMELUZ, LEVULAN KERASTICK
- Application Number
- NDA208081
- Sponsor
- LYOCONTRACT GmbH
- NDC Codes
- 3
- Dosage Forms
- FOR SOLUTION, GEL, KIT
- Routes
- TOPICAL
- Active Ingredients
- AMINOLEVULINIC ACID HYDROCHLORIDE
Indications and Usage
1. INDICATIONS AND USAGE AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED ® or RhodoLED ® XL lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp. AMELUZ, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED or RhodoLED XL lamp, is indicated for the lesion-directed and field-directed treatment of actinic keratoses (AK) of mild-to-moderate severity on the face and scalp ( 1 ).