REMS@FDA Updates

Summary of REMS@FDA Website Updates for January 2022 1. Spravato (esketamine) modified on January 3, 2022 to reflect changes to the Spravato REMS Patient Monitoring Form, including revisions to the format of some of the data-capturing fields and the addition of a field to capture the lot number field of Spravato. 2. Xiaflex (collagenase clostridium histolyticum) modified on January 11, 2022  to update the REMS materials to reflect the safety labeling changes that were recently approved on August 19, 2021 and approved labeling regarding penile hematoma. 3. Yescarta and Tecartus (axicabtagene) modified on January 25, 2022 to update the U.S. Prescribing Information with clinical safety data from Cohort 6 of the Phase 2 Safety Management ZUMA-1 study. 4. Adasuve (loxapine) modified on January 27, 2022 to make the following changes: adding that a short-acting bronchodilator (e.g., albuterol) by inhaler, with spacer, is an acceptable option to treat bronchospasm caused by Adasuve removal of the requirement to ensure all relevant staff are trained and replaced with a requirement that the healthcare setting have processes and procedures to ensure the safe use of Adasuve removal of the every 15 minute monitoring requirement removal of the need for post-dose chest auscultation conversion of the REMS Document to the new standardized format In addition, the REMS goal was modified to reflect the above changes. 5. Opioid Analgesic REMS added the following: Morphine sulfate tablets, ANDA 207270 Acetaminophen, butalbital, caffeine, and codeine phosphate, ANDA 215138  6. Mycophenolate Shared System REMS added ANDA 211272  7. Pomalidomide Shared System REMS added ANDA 210275 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