Biofrontera AG, of Leverkusen, Germany, said the FDA approved the combination of topical drug Ameluz (BF-200 ALA) and medical device BF-Rhodoled for photodynamic therapy treatment of mild to moderate actinic keratosis on the face and scalp. The approval covers lesion-directed as well as field-directed treatment. Ameluz received EMA approval in December 2011, with BF-Rhodoled approved as a medical device in the EU in November 2012.