Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 3/27/14

Zyban (bupropion hydrochloride) Sustained-Release Tablets REMS

Goals of the Zyban (bupropion hydrochloride) Sustained-Release Tablets REMS Program

The goal of this REMS is to inform patients about the potential serious risk of neuropsychiatric adverse events associated with the use of ZYBAN.

REMS Elements

• Medication Guide