Regulatory Actions
AVANIR Receives FDA Approval for New Formulation of Currently Marketed Antipsychotic Drug FazaClo
Published in Medical Letter on the CDC and FDA, June 17th, 2007
AVANIR Pharmaceuticals (NASDAQ:AVNR) announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for a new formulation of the currently marketed antipsychotic drug FazaClo(R) (clozapine, USP) Orally Disintegrating Tablets. The new formulation provides bottle packaging and a new 12.5 mg dosage strength, in addition to 25 mg and 100 mg dosage strengths. Previously FazaClo was only available in 25 mg and 100 mg dosage strengths in special blister packaging. The new formulation of FazaClo in bottles is expected to be more convenient for health care professionals and patients, and will be available in pharmacies shortly.
"The new...
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