Summary of REMS@FDA website updates for May, 2018

1. Kymriah (tisagenlecleucel) REMS modified REMS training materials May 1, 2018 to align with labeling changes related to the new indication and updates the REMS Document to the new format. 2.  Addyi (flibanserin) REMS revised May 9, 2018 to make an editorial change. 3. Emtricitabine/tenofovir disoproxil fumarate Shared System REMS modified May 15, 2018 to reflect expansion of the PrEP indication to include the adolescent patient population based on the revisions to the indication. 4.  Palynziq (pegvaliase-pqpz) REMS approved May 24, 2018. 5. Iclusig REMS revised May 7, 2018 to make an editorial change. Iclusig REMS released May 29, 2018.