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Monday December 1, 10:42 am Eastern Time
Company Press Release
SOURCE: IVAX Corporation
IVAX Announces Generic Drug Approval For Clozapine
MIAMI, Dec. 1 /PRNewswire/ -- IVAX Corporation (Amex: IVX - news) today announced that the United States Food and Drug Administration approved an Abbreviated New Drug Application for the generic pharmaceutical product clozapine in 25 mg and 100 mg tablets. Clozapine is indicated for the management of schizophrenic patients who fail to respond adequately to standard antipsychotic drug treatment, and is the generic equivalent of Novartis Corporation's Clozaril(R). The product will be marketed by IVAX's wholly- owned subsidiary, Zenith Goldline Pharmaceuticals, Inc., and sales will commence immediately.
Zenith Goldline has implemented a patient monitoring system, the Clozapine A.L.E.R.T. Program(TM), to comply with the regulatory requirement of monitoring the white blood cell counts of patients taking clozapine. The Clozapine A.L.E.R.T. Program(TM) is the first and only patient monitoring system for generic clozapine. The purposes of this program are to foster early detection of white blood cell suppression, a potential side effect of this drug, and to help ensure that patients at risk for white blood cell suppression are not treated with clozapine.
''The Clozapine A.L.E.R.T. Program(TM) requires extensive medical and database resources and is a unique undertaking for a generic company. We are pleased to be the first company to offer a generic version of clozapine with such a program,'' said Zenith Goldline's President and Chief Executive Officer, Dr. Rafick G. Henein. ''Our product allows us to provide an effective and affordable treatment for those suffering from severe schizophrenia and is another example of Zenith Goldline Pharmaceuticals' ability to launch generic products that are difficult to develop.''
IVAX Corporation, headquartered in Miami, Florida, is a holding company with core subsidiaries engaged primarily in the research, development, manufacture and marketing of generic and branded
pharmaceuticals.
SOURCE: IVAX Corporation |
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