|
REMS@FDA Updates for July 2026
1. Vanflyta (quizartinib) revised on July 1st to make editorial changes. 2. Zyprexa Relprevv (olanzapine) revised on July 6th to make editorial changes 3. Buprenorphine Transmucosal Products for Opioid Dependence Shared System REMS modified on July 10th to include additional strengths of buprenorphine sublingual tablets, 4mg and 12mg, to the table of available products in the Important Safety Information for Prescribers, and Important Safety Information for Pharmacists. 4. Fabhalta (iptacopan) modified on July 16th to consist of changes to the Healthcare Provider Safety Brochure, Patient Guide, and REMS Website to align with the revised indication to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. 5. Miudella (copper) revised on July 21st to include updates to company name and phone numbers to report adverse events. 6. Tyruko (natalizumab-sztn) modified on July 23rd to consist of changes to the REMS Assessment Timetable to support accurate reporting of progressive multifocal leukoencephalopathy (PML) incidence across all natalizumab products. 7. Mycophenolate and PS-Mycophenolate REMS released on July 29th. 8. Lynozyfic (linvoseltamab-gcpt) modified on July 31st to consist of updates to the Pharmacy and Healthcare Setting Enrollment Form to require the Authorized Representatives to include the DEA# or HIN#, changes to the REMS Website to include the changes to the Pharmacy and Healthcare Setting Enrollment Form, add a link to the Haitian Creole Patient Wallet Card, add search functionality to the DEA# field, and clarify Pharmacy Authorized Representative Screenshots to show an updated enrollment success message for specialty pharmacies and other pharmacies, and to change the copyright year and product logo the Trademarked (TM) to the Registered (R) designation.
|