Taxotere Submission In USA, Canada And EU
Rhone-Poulenc Rorer has submitted license applications for its anticancer drug Taxotere (docetaxel) in the major markets of the USA, Canada and Europe. The applications are for use in breast cancer and non-small cell lung cancer.
The product will be reviewed in the European Union under the concertation procedure with France acting as rapporteur. Germany and Portugal will be the co-rapporteurs.
The submissions in the USA, Canada, France, Germany, Portugal, Sweden, Norway and Finland follow the May license application for the drug in Japan. The license applications include data collected from over 1,500 patients involved in more than 35 studies. The company says that the drug is its top priority product on a worldwide basis.
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