Pfizer's Zeldox approvable in USA
Pfizer has received an approvable letter from the US Food and DrugAdministration for Zeldox (ziprasidone) and is now discussing the drug's labeling with the agency. The company was forced to conduct another large trial of the drug in schizophrenia patients after the FDA rejected an initial marketing application on concerns over a link with QT prolongation. Zeldox was recommended for approval by an FDA advisory committee in July (Marketletter July 24), and it was recently approved in Sweden (see page 23).
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