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U.S. Department of Health and Human Services

Safety

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Zyflo CR (zileuton) Extended Release Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2011

 

Summary View

WARNINGS AND PRECAUTIONS

USE IN SPECIFIC POPULATIONS

Pediatric Use
  • FDA has not required pediatric studies in patients under the age of 12 years due to the risk of hepatotoxicity. Zyflo CR is not appropriate for children less than 12 years of age