Ivax Corporation has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for clozapine tablets USP, 50 mg. This product will be sold through Ivax' wholly owned subsidiary, Ivax Pharmaceuticals, Inc.

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 mg, 25 mg and 12.5 mg tablet dosage strengths. Ivax' 50 mg tablet is a new dosage strength developed by Ivax to facilitate dose titration, minimize the risk of side effects and to create additional dosing options.

According to IMS data, annual US sales for Clozaril and its generic equivalent, clozapine were $182 million for 2004. Ivax currently has a market share of 50% of the total (Clozaril and clozapine combined) market's extended units.