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Bayer/GlaxoSmithKline Levitra EU opinion

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bayer/GSK's erectile dysfunction therapy Levitra (vardenafil) receives a positive opinion Nov. 21 from European Committee for Proprietary Medicinal Products. Bayer says the opinion was received earlier than anticipated. Levitra 10 mg and 20 mg were shown to have 82% and 86% average success rates, respectively, in data presented at the European Society for Sexual and Impotence Research in early December. The companies anticipate a first-half 2003 European launch; U.S. approval is also expected in 200

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