DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

We also acknowledge receipt of your amendments dated January 9, 2016, February 3, 2016, March 22, 2016, March 28, 2016, April 15, 2016, June 15, 2016, and June 16, 2016. These Prior Approval supplemental new drug applications provide for proposed modifications to the approved Sabril (vigabatrin) risk evaluation and mitigation strategy (REMS) and corresponding changes to the Sabril (vigabatrin) Prescribing Information and Medication Guide. The supplements, as amended, were submitted in response to our October 6, 2015, REMS Modification Notification letter.