Denmark's H Lundbeck said today it will put back filing for approval of its new schizophrenia drug bifeprunox until 2008 in Europe as it carries out additional Phase III testing.
Bifeprunox was originally scheduled to be filed for US, Canadian and European approval in 2006, and launched in these markets in 2007. In a statement, Lundbeck said: "further clinical work will be needed to clarify the clinical profile and strengthen the registration dossier."
Sounds a bit fishy to Insider. Is there a story here? They have had problems with atypical antipsychotics in the past.........Insider has a long memory!
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