11 May 2016 - Biofrontera today announced that the U.S. FDA has granted approval of its combination topical prescription 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 and follows thorough review of the company’s new drug application, which was submitted in July 2015.

Ameluz was granted marketing authorization by the EMA in December 2011 for the treatment of mild and moderate actinic keratosis on the face and scalp. BF-RhodoLED was approved as a medical device in the EU in November 2012.

For more details, go to: http://biofrontera.com/en/investors/ad-hoc-news.html