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Biofrontera Announces U.S. FDA Approval of Ameluz and Activating BF-RhodoLED Device for Treatment of Actinic Keratosis
Posted 8 Jun 2016 by Drugs.com
Leverkusen, Germany, May 11, 2016 – Biofrontera AG (FSE: B8F), the specialist for the treatment of sun-induced skin cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of its combination topical prescription drug Ameluz (BF-200 ALA) and medical device BF-RhodoLED® for photodynamic therapy (PDT) treatment of mild to moderate actinic keratosis (AK) on the face and scalp. The approval covers lesion-directed as well as field-directed treatment and follows thorough review of the Company’s New Drug Application (NDA), which was submitted in July 2015. This marks an outstanding accomplishment for a start-up company that is rarely seen in European companies of comparable size. It is the fourth marketing approval of Ameluz worldwide and further validates the comprehensive safety and efficacy data from the Company’s three pivotal multi-center clinical trial ... Read more