www.fdanews.com/articles/176645-fda-greenlights-biofronteras-drug-device-combo-for-actinic-keratosis
FDA Greenlights Biofrontera’s Drug-Device Combo for Actinic Keratosis
May 13, 2016
The FDA has approved Biofrontera’s drug-device topical Ameluz and BF-RhodoLED for treatment of mild to moderate actinic keratosis on the face and scalp, the German startup announced Wednesday.
The combination uses photodynamic therapy to target lesions caused by prolonged exposure to UV rays.
Ameluz was granted marketing authorization by the EMA in December 2011 for the same indication, and the device was approved in the EU in November 2012. — Anisa Jibrell