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J&J Concerta Psychiatric Adverse Event Labeling Change Proposed By FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Post-marketing adverse event reports spur the labeling change for Concerta and other methylphenidate ADHD therapies. The agency is also examining adverse event reports for amphetamine ADHD therapies and Lilly's Strattera to determine if there is a similar risk.
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