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# REMS Updates Announced
- URL: https://www.fdaweb.com/rems-updates-announced/
- Published: 2016-02-16T12:00:00.000Z
- Updated: 2026-09-15T02:35:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134776

> FDA says the following updates have been made to the REMS@FDA approved Risk Evaluation and Mitigation Strategies (REMS) [Web site](http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?ref=fdaweb.com). Changes include:  
> Sanofi Aventis Multaq REMS released 2/12; PF Prism Xeljanz REMS released 2/8; Isotretinoin iPLEDGE shared system REMS modified 2/4 to increase awareness and compliance with the appropriate classification of female patients of reproductive potential on the iPLEDGE Web site; Novo Nordisk Saxenda REMS modified 2/1 to modify the REMS document for consistency with presentation of current consumer/product Web sites; Prometheus Labs Lotronex REMS and alosetron REMS modified 1/7 to modify the REMS goal, remove the Medication Guide as a REMS element, and modify the elements to assure safe use; Transmuscosal immediate-release fentanyl shared system REMS modified 12/21/15 to revise the Medication Guide to include the new strength of 300 mcg per spray; and Alkermes Vivitrol REMS modified 12/8/15 to change the appended materials including a poster and a Dear Healthcare Provider letter.