Approvals in Europe for Ipsen's Decapeptyl, and Novartis and Sanofi flu drugs

French drugmaker Ipsen says that the French regulatory authorities, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has granted a marketing authorization for its six-month sustained-release formulation of Decapeptyl (triptorelin embonate 22.5mg) for the treatment of locally-advanced and metastatic prostate cancer. The launch of the six-month formulation in France by Ipsen should take place during the first semester of 2010.

Last October, Ipsen and Debiopharm Group announced the successful completion of the European decentralized registration procedure involving nine countries: Germany (reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain and the Netherlands while, for other European countries (Portugal, UK, Ireland, Italy, Romania and Lithuania), the marketing authorization applications were filed as a national line extension to the existing Decapeptyl's ones. France is the first country to approve Decapeptyl six-month in the context of the decentralized procedure in Europe.

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