FDA okays Teva's clozapine tablets 25 mg, 100 mg

The drug is the generic equivalent of Novartis' antipsychotic agent Clozaril.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced yesterday that the US Food and Drug Administration has granted final approval for the its abbreviated new drug application (ANDA) for clozapine tablets, 25 mg and 100 mg. Shipment of this product is expected to begin immediately.

Teva's clozapine tablets are the AB-rated generic equivalent of Novartis' antipsychotic agent Clozaril tablets.

Total annual sales of this product, including brand and generic sales, are approximately $183 million.

Published by Globes [online], Israel business news - www.globes.co.il - on Thursday, April 28, 2005

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