Treats actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp. NDA 208081, held by Biofrontera. Aminolevulinic Acid Hydrochloride.
As of Nov 14, 2026, NDA 208081 (Ameluz), held by Biofrontera, was first approved by FDA on May 10, 2016, with 5 approved supplements and 0 published complete response letters.
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 in adults. the treatment of superficial basal cell carcinoma (sBCC) in adults. AMELUZ, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED or RhodoLED XL lamp, is
| Sep 9, 2026 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Oct 4, 2024 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| May 10, 2016 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ameluz10% · gel;topical | Aminolevulinic Acid Hydrochloride | RxReference drug |
| Sep 9, 2026 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Oct 4, 2024 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Mar 11, 2024 | Supplement 26Manufacturing | Approved | |
| May 25, 2021 | Supplement 11Labeling · Standard review | Approved | |
| Sep 6, 2017 | Supplement 2Labeling · Standard review | Approved | |
| May 10, 2016 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
