Summary of REMS@FDA Website Updates for May 2022

Summary of REMS@FDA Website Updates for May 2022 1. Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) Shared System REMS modified May 3, 2022 to: add language regarding healthcare providers discussing the availability of naloxone, assessing each patient's need for a naloxone prescription, and co-prescribing naloxone if appropriate; and the updated Department of Health and Human Services (HHS) Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder reflect language from the Safety Related Labeling Changes approved on 3/4/2021 and additional revisions in the Appropriate Use Checklist, Prescriber and Pharmacist Letters, Prescriber and Pharmacist Brochures, and REMS Website update REMS materials to include Subutex and Suboxone products. 2.  Alosetron Shared System REMS modified May 5, 2022 to make:   Changes to the Prescriber Education Slide Deck to align with the REMS modification approved October 18, 2021  Changes in the REMS website to add a link to the "Letter for Healthcare Providers" and to update the Terms of Use page version and date information. 3. Prolia (denosumab) REMS modified May 19, 2022 to revise the Medication Guide to clarify that Prolia is not approved for use in pediatric patients. 4. Camzyos (mavacamten) REMS revised May 26, 2022 to make an editorial change.  5. Aveed (testosterone undecanoate) REMS modified May 26, 2022 to update the REMS supporting document and the website screenshots due to a website administrator change. 6. Kymriah REMS modified May 27, 2022 to make changes to the REMS Patient Wallet Card, Live Training Program, Knowledge Assessment, and REMS Program Website to align with labeling changes related to the new indication for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. 7. Pomalidamide Shared System REMS added ANDA 209956. 8. Vigabatrin Shared System REMS added ANDA 215601. 9.  Opioid Analgesic Shared System REMS added ANDA 207490. 10. Ambrisentan Shared System REMS added ANDA 210701. 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