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U.S. Department of Health and Human Services


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Zenpep (Pancrelipase) Delayed-release Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

Summary View



Postmarketing Experience
  • Postmarketing data for Zenpep have been available since 2009. The following adverse reactions have been identified during post-approval use of Zenpep…


Dosing and Administration
  • Instruct patients and caregivers to notify the healthcare professional if the patient has a history of abnormal glucose levels before initiating treatment with Zenpep.
  • Pregnancy and Breast Feeding - Instruct patients to notify their healthcare professional if they are pregnant or thinking of becoming pregnant during treatment with Zenpep…