FDA Approves IVAX Generic Clozapine
IVAX Corp has announced that the US Food and Drug Administration hasapproved an Abbreviated New Drug Application for its generic form of clozapine in 25mg and 100mg tablets. IVAX becomes the first company to offer a generic version of clozapine, which is used in the management of schizophrenia. The Miami-based company said that the product, which is the generic equivalent of Novartis' Clozaril, will be marketed by its subsidiary Zenith Goldline Pharmaceuticals, and sales are to commence immediately.
Zenith Goldline has implemented a patient-monitoring system, the Clozapine ALERT program, to comply with the regulatory requirement of monitoring the white blood cell counts of patients taking the drug, in order to foster early detection of agranulocytosis, a potential side effect of clozapine.
IVAX says that the program is the first and only patient-monitoring system for generic clozapine, while the product allows it to provide "an effective and affordable treatment."
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