Approved Risk Evaluation and Mitigation Strategies (REMS)

Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA has been updated with the following new or updated information.

•  Extended-release and long-acting (ER/LA) opioid analgesics shared system REMS-specific page (updated on June 26, 2015). The changes are to the ER/LA Opioid Analgesics REMS Blueprint for Prescriber Education to incorporate:

1. Product-specific information for a recently approved ER/LA opioid analgesic, Hysingla ER (hydrocodone bitartrate extended-release) tablets
2. Newly approved intermediate strengths of fentanyl transdermal systems
3. Revised titration information for Dolophine (methadone HCl tablets).