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EMA approves Biofrontera's BF-200 ALA

24.10.2011

Leverkusen - A short statement from the European Medicines Agency (EMA) and a big step for the German biotech Biofrontera. The agency issued a favourable opinion on Biofrontera's marketing approval application for its drug for the treatment of actinic keratosis. There was no recommendation for a restriction or temporal limitation of the approval. The substance, which Biofrontera addressed as BF-200 ALA while in development, will be marketed under the name Ameluz. The positive assessment report by the Committee for Medicinal Products for Human Use (CHMP) will now be forwarded to the European Commission for the formal conclusion of the process. Biofrontera anticipates final approval in December. After that, Ameluz can be commercialised in all 27 countries of the EU as well as Norway, Iceland and Liechtenstein, the company stated. Biofrontera had started its application process in September 2010.

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