First Approval For Pfizer's Zeldox
Pfizer's new atypical antipsychotic Zeldox (ziprasidone) has beenapproved for marketing in Sweden, the first country to register the drug worldwide. The drug is indicated for the treatment of acute schizophrenia and also as a maintenance therapy to sustain clinical improvements through prolonged use.
The Swedish labeling for Zeldox notes that the drug causes a prolongation of the QT interval on electrocardiogram, and contraindicates its use in those who already have this effect. While it is not clear if this effect was behind the issuance of a "not approvable" letter for Zeldox in the USA in June, it was the reason why Abbott withdrew its application there for its antipsychotic Serlect (sertindole) in January.
Zeldox is under review in the European Union under the mutual recognition procedure, with Sweden acting as rapporteur.
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