Ivax, Teva Receive Final FDA Approval for Generic Clozaril

The FDA has granted Ivax Pharmaceuticals final approval for its abbreviated new drug application for a 50-mg dose of clozapine tablets.

The FDA also gave Teva Pharmaceutical final approval for clozapine tablets in 25- and 100-mg doses. Clozapine is the generic version of Novartis' Clozaril, which is used to treat schizophrenia.

Clozapine tablets are currently available in the U.S. in 100-, 25- and 12.5-mg tablets. U.S. sales for brand and generic clozapine products totaled $182 million for 2004, according to IMS Health data.