Schering AG's Finacea cleared in EU
Schering AG of Germany has been granted marketing authorization in theEuropean Union for use of its Finacea (azelaic acid) 15% Gel as a topical treatment for papulopostular rosacea, a chronic skin condition. The decision was based on data from three multicenter, randomized, double-blind trials involving a total of 915 patients.
The product is already available in the USA (Marketletter March 31) and is also marketed in Germany, Poland, Switzerland, Finland and South Africa, under the trade name Skinoren, for this indication. Furthermore, the agent was originally approved in the EU in 2002 as a treatment for acne.
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