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Ameluz Approval History

Reviewed on May 10, 2016 by J.Stewart BPharm.

  • FDA approved: Yes (First approved May 10th, 2016)
  • Brand name: Ameluz
  • Generic name: aminolevulinic acid
  • Dosage form: Gel
  • Previous name: BF-200 ALA
  • Company: Biofrontera AG
  • Treatment for: Actinic Keratosis

Ameluz (aminolevulinic acid) is a porphyrin precursor used in combination with the BF-RhodoLED lamp for photodynamic therapy (PDT) treatment of actinic keratoses on the face and scalp.

FDA approval of Ameluz was based on safety and efficacy data from three pivotal multi-center clinical trials evaluating 779 patients with four to eight mild-to-moderate actinic keratosis (AK) lesions. Results demonstrated a complete patient response rate of 91% when paired with BF-RhodoLED PDT lamp.

Ameluz gel is applied to AK lesions by a healthcare professional, and then covered with a light blocking, occlusive dressing for three hours. After that time the gel is removed, and the area is illuminated with BF-RhodoLED red light. Ameluz increases photosensitivity, and patients should avoid exposure to sunlight, prolonged or intense light (such as tanning beds, sun lamps) for approximately 48 hours following treatment.

Common side effects include local skin reactions such as redness, pain/burning, itching and swelling.

Development History and FDA Approval Process for Ameluz

May 11, 2016Approval Biofrontera Announces U.S. FDA Approval of Ameluz and Activating BF-RhodoLED Device for Treatment of Actinic Keratosis
Sep 11, 2015FDA Accepts Filing of Ameluz and BFRhodoLED New Drug Application
Jul 13, 2015Biofrontera Submits New Drug Application for Ameluz to FDA
Sep 27, 2011Biofrontera delivers final documents for processing the last open issues in the drug application of BF-200 ALA
Jan  6, 2010Detailed phase III results confirm superiority of BF-200 ALA over Metvix

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