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FDA Approves Ameluz for Actinic Keratosis

Biofrontera news release; 2016 May 11

The FDA has approved Ameluz (aminolevulinic acid hydrochloride; Biofrontera) gel, for the treatment of mild-to-moderate actinic keratosis (AK) on the face and scalp.

Indications: Ameluz gel is a porphyrin precursor, which is used in combination with photodynamic therapy using the BF-RhodoLED lamp. It is indicated for lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp.

Dosage/administration: Each gram of Ameluz gel 10% contains 100 mg of aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid). Ameluz gel is to be administered by a health care provider and is for topical use only. Photodynamic therapy with Ameluz involves preparation of lesions, application of the product, and occlusion and illumination with BF-RhodoLED. Lesions that have not completely resolved 3 months after the initial treatment should be retreated.

Adverse reactions: The most common adverse reactions (≥10%) were application site erythema, pain/burning, irritation, edema, pruritis, exfoliation, scab, induration, and vesicles.

Citation: Biofrontera announces US FDA approval of Ameluz and activating BF-RhodoLED device for treatment of actinic keratosis. [news release]. Leverkusen, Germany: Biofrontera; May 11, 2016: Accessed May 11, 2016.

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FDA Approves Ameluz for Actinic Keratosis, Biofrontera news release; 2016 May 11