The priority review is granted to applications in which a new indication or new drug product, if
approved, has a potential to present a safe and effective therapy where no satisfactory alternative
exists compared to currently available therapies or marketed products. A registration dossier is also under regulatory review by the European Medicines Agency (EMEA) for a Marketing Authorization Application.
FDA Assigns Priority Review Status for Sanofi Aventis' Multaq
Published on : Mon, 25 Aug 2008
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