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Ameluz Approval History

FDA Approved: Yes (First approved May 10, 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.

Development History and FDA Approval Process for Ameluz

DateArticle
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

Further information

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