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
