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J&J paliperidone ER "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Johnson & Johnson's extended-release schizophrenia agent paliperidone is "approvable" Sept. 29; J&J says it will "work quickly to resolve the agency's questions." Earlier in September, the company had indicated that it expected an approvable decision. J&J submitted the follow-on compound to its blockbuster atypical antipsychotic Risperdal (risperidone) in December 2005 (1Pharmaceutical Approvals Monthly December 2005, In Brief)...

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