You are here
Orally Disintegrating Form of Clozapine Issued Approvable Letter
"The new packaging and 12.5mg strength of FazaClo, if approved, will provide additional convenience benefits to patients, pharmacies, and institutions," said Randall E. Kaye, M.D., Vice President of Clinical and Medical Affairs of Avanir. "While maintaining the unique benefits of the orally disintegrating tablet, this new formulation and packaging will provide patients with more convenient access to FazaClo as the need for blister packaging will be eliminated. This new formulation will allow the tablets to be packaged in standard bottles that will enable pharmacies and institutional customers that administer FazaClo to store and dispense the medication in a manner consistent with other formulations of clozapine. Additionally, the 12.5mg dosing strength will enhance the ability of physicians to easily titrate and fine tune the dosing of FazaClo for their patients."
Of the two-and-a-half million Americans who suffer from schizophrenia, approximately one-third are termed treatment-refractory because they derive little or no benefit from conventional antipsychotic medications. FazaClo® (clozapine, USP), is indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia and is indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state FazaClo is currently supplied in an innovative orally disintegrating tablet that uses the proprietary OraSolv™ technology licensed from CIMA LABS INC. FazaClo is designed to disintegrate in the mouth in about 15 to 30 seconds with a pleasant mint flavor and is then swallowed reflexively in saliva. This advantage may be important in treating a disease such as schizophrenia where non-compliance is a significant problem leading to relapse and potential hospitalization. Because of the risk of agranulocytosis and granulocytopenia associated with the use of clozapine, Avanir maintains the FazaClo Patient Registry. Prescribing health care practitioners, dispensing pharmacists and FazaClo patients can be registered in the FazaClo Patient Registry, which will compare patient information against the National Non-Rechallenge Masterfile and maintain a continuing record of total white blood cell (WBC) counts and absolute neutrophil count (ANC) values and related information for patients who receive the FazaClo brand of clozapine. Please see full Prescribing Information including BOXED WARNINGS regarding agranulocytosis, seizures, myocarditis, dementia-related psychosis in elderly patients, and other adverse cardiovascular and respiratory effects at www.fazaclo.com.
Source: Avanir Pharmaceuticals