FDA approves Avanir's new form of clozapine
California, USA-based Avanir Pharmaceuticals has received marketing approval from the Food and Drug Administration for a new formulation of the currently marketed antipsychotic drug FazaClo (clozapine, USP) orally-disintegrating tablets. This provides bottle packaging and a new 12.5mg dosage strength, in addition to 25mg and 100mg dosage strengths. Previously, FazaClo was only available in 25mg and 100mg dosages in special blister packaging. The new formulation in bottles is expected to be more convenient for health care professionals and patients, and will be available in pharmacies shortly, says the firm.
Avanir received an approvable letter in January for this new formulation of FazaClo. Final clearance was granted after addressing the FDA concerns raised in that communication.
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