www.fdanews.com/articles/74400-avelox-iv-approved-in-europe-to-treat-complicated-skin-and-skin-structure-infections
AVELOX IV APPROVED IN EUROPE TO TREAT COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
July 18, 2005
Bayer HealthCare today announced that Avelox® IV (moxifloxacin HCl, solution for Infusion) was approved for the treatment of complicated Skin and Skin Structure Infections (cSSSI). The approval procedure which was led by the German Regulatory Authority, (German Federal Institute for Drugs and Medical devices -- BfArM), was successfully completed for this new indication in all 17 European Member States where Avelox IV is licensed.1 Last month, the United States Food and Drug Administration (FDA) approved the cSSSI indication for the USA where Schering-Plough Corporation has acquired the marketing rights for Avelox®.
PharmaLive