IVAX receives FDA approval to sell generic Clozaril for schizophrenia

By Angela McDaniels

Seattle, Dec. 19 - IVAX Corp. said it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for clozapine tablets USP, 200 mg.

Clozapine is the generic equivalent of Clozaril, which is marketed by Novartis and used in the treatment of schizophrenia. The drug is currently available in 100, 50, 25 and 12.5 mg tablet dosage strengths.

The 200 mg tablet is a new dosage strength developed by IVAX to create additional dosing options and will be sold through subsidiary IVAX Pharmaceuticals Inc.

Annual U.S. sales for Clozaril and clozapine were $135.5 million for the 12 months ended Sept. 30, the company said.

IVAX said it has a market share of 53% of the total market's extended units.

IVAX is headquartered in Miami and develops branded and generic pharmaceuticals and veterinary products.

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