February 01, 2007

Orally Disintegrating Form of Clozapine Soon to be Approved

Avanir Pharmaceuticals (NASDAQ: AVNR) announced today that it has received an "approvable letter" from the U.S. Food and Drug Administration (FDA) for a new formulation of its currently marketed antipsychotic drug FazaClo(clozapine, USP). The new formulation, if approved, will include updated packaging as well as a new 12.5 mg dosing strength.

Avanir is preparing its response to the FDA and currently anticipates resolving the issues to obtain final marketing approval in the coming months. FazaClo is the only orally disintegrating form of clozapine which is indicated for the management of severely ill schizophrenia patients who fail to respond adequately to standard schizophrenic drug treatments. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenia or schizoaffective disorder.

More Information: www.fazaclo.com

Additional Reading:


Genetic Test for Predicting Risk From Clozapine Becomes Available

CATIE Trials Information on Clozaril


The MNCs are closing for the kill. As the efficacy of this drug is being proven and the lie they have been telling about AGRANULOCYTOSIS is being resolved, the LOW DOSAGE of this drug as in switzerland is being introduced now.They are culpable of LIE about hiding the efficacy of CLOZAPINE ALL THESE YEARS.

Posted by: captainjohann, BANGALORE, INDIA at February 2, 2007 12:48 AM

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