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Home » Ivax, Teva Receive Final FDA Approval for Generic Clozaril
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.
KEYWORDS Drug Pipeline Alert
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