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U.S. Department of Health and Human Services

Safety

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Accolate (zafirlukast) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009

 

Summary View

 

PRECAUTIONS

  • Neuropsychiatric Events was added as a separate subsection

ADVERSE REACTIONS

  • Neuropsychiatric adverse events with the terms “depression” and “insomnia” were added