Summary of REMS@FDA Website Updates for January and February, 2021

Summary of REMS@FDA Website Updates for January and February, 2021 1. Mycophenolate Shared System REMS modified January 15, 2021 to: Revise the patient-directed goal to make the language more patient-friendly and to align with the Medication Guide. Eliminate the Patient-Prescriber Acknowledgement Form to reduce burden on stakeholders. Create two versions of the Center & Prescriber Training Confirmation Forms, Healthcare Provider Brochure, Center & Healthcare Provider Letters, & REMS website to address the availability of training prior to and after Continuing Education becomes available. Include a list of professional medical societies and publishing schedule for the website banner. 2. Siliq (brodalumab) REMS modified January 22, 2021 to reflect the following: Conversion of the REMS Document to the new, standardized format. Removal of the word "Program" from the titles of the REMS materials to reflect current practice on naming. Changes to the Stakeholder Enrollment Form instructions to improve clarity and removal of the DEA field as brodalumab is not a controlled substance. Changes to the Patient Enrollment Form to expand the gender categories to improve inclusivity. Changes to the REMS materials to align with changes to the REMS Document. 3. Breyanzi (lisocabtagene maraleucel) REMS  approved February 5, 2021. 4. Xywav (calcium, magnesium, potassium, and sodium oxybates) and Xyrem (sodium oxybate) REMS modified February 11, 2021 to make revisions to the most common side effects in pediatric patients listed in the Patient Counseling Checklist, Prescriber Brochure, the Xyrem and Xywav Brochures for Pediatric Patients and their Caregivers, and the REMS Supporting Document to conform with a recently approved prior approval supplement. Modified to revise the REMS document, REMS supporting document, and appended REMS materials to allow for the addition of an authorized generic for Xyrem. 5. Gattex (teduglutide [rDNA origin]) REMS modified February 11, 2021 to update the REMS website to add a link for prescriber re-training. 6. Clozapine Shared System REMS modified February 18, 2021 to: Remove reference to Fazaclo (clozapine) and Jazz Pharmaceuticals Inc. from the following materials: -Clozapine and Risk of Neutropenia: A Guide for Healthcare Providers -Clozapine REMS Website. Add a previously approved generic formulation for orally disintegrating tablet produced by Teva (ANDA203039) to the generic products table on the REMS website. 7. Vigabatrin Shared System REMS added ANDAs 213519 and 211539. 8. Mycophenolate Shared System REMS added ANDAs 214376 and 212130. 9. Opioid Analgesic REMS added morphine sulfate oral solution, ANDA 211454.   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