Label Changes for:

Zenpep (Pancrelipase) Delayed-release Capsules

April 2013

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

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

 

ADVERSE REACTIONS

Postmarketing Experience
  • Postmarketing data for Zenpep have been available since 2009. The following adverse reactions have been identified during post-approval use of Zenpep…
 
Hide
(web3)