Summary of REMS@FDA Website Updates for March and April, 2021

Summary of REMS@FDA Website Updates for March and April, 2021 1. Blincyto (blinatumomab) REMS modified March 11, 2021 to include restricting the indications to patients who are CD19-positive to the REMS materials. 2. Lemtrada (alemtuzumab) REMS modified March 12, 2021 to include the following: Changes to the REMS materials to align with the labeling changes in supplements 5177 and 5179, which were approved on September 25, 2020 Changes to enable online enrollment of patients (and to enable an online digital signature for LEMTRADA REMS patient enrollment forms) Changes to allow pharmacies to obtain authorization to ship product online via www.lemtradarems.com Incorporation of formatting, layout, and wording changes to the Infusion Checklist to provide clarity and consistency with LEMTRADA REMS materials Consolidation of selected REMS materials in order to eliminate redundancy Change in the timeframe to return unused Lemtrada vials from 50 business days to 75 business days Addition of a Patient Transfer of Care Form as a new REMS material. 3. Abecma (Idecabtagene vicleucel) REMS approved March 26, 2021. 4. Qsymia (phentermine and topiramate) REMS modified March 31, 2021 to replace gender-specific language in the REMS document and REMS materials with gender-neutral language. This modification aligns the REMS document and REMS materials with changes previously made to the Qsymia prescribing information. 5. Macitentan Shared System REMS approved April 6, 2021. 6. Mycophenolate Shared System REMS modified April 26, 2021 to update the non-Continuing Education (CE) website screenshots to include a link on the homepage for the CE Request for Application (RFA). ANDA 211374 added March 10, 2021. 7. Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) REMS modified the REMS materials April 22, 2021 to align with labeling changes related to the approval of Yescarta for management of cytokine release syndrome and neurological toxicities. 8. Zyprexa Relprevv (olanzapine) REMS modified April 28, 2021 to make updates to the Privacy Policy page of the Zyprexa Relprevv (olanzapine pamoate) Patient Care Program (PCP) Website to meet current requirements, including updating and hyperlinking of the California Privacy Policy Statement. 9. Opioid Analgesic REMS added hydrocodone bitartrate, ANDA 208269. 10. Isotretinoin iPLEDGE REMS added ANDAs 205063 and 213571.  Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA