Label Changes for:

Accolate (zafirlukast) tablets

August 2009

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

PRECAUTIONS

  • Neuropsychiatric Events was added as a separate subsection

ADVERSE REACTIONS

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