Summary of REMS@FDA website updates for October, 2018

1.  Ionsys (fentany iontophoretic transdermal system) REMS modified October 3, 2018 to change the timing of the audits of the certified hospitals.

2. Tegsedi (Inotersen) REMS approved October 5, 2015 and revised to reflect a change in ownership.

3.  Siliq (brodalumab) REMS modified October 9, 2018 to remove the Website Consent section of the SILIQ REMS Program Prescriber Enrollment Form by  which prescribers authorize the publishing of their information on the REMS website, and removal of the listing of certified prescribers from the REMS website.

4.  Opsumit (macitentan) REMS modified October 16, 2018. Modified: 

• to reflect the revised Indication Statement
• the Guide for Females Who Can Get Pregnant to incorporate information on females who cannot get pregnant and retitle it as Guide for Female Patients
• the Prescriber and Pharmacy Guide and website to include the updated indication and updated language in the "Risk of teratogenicity" section to align with the updated labeling and incorporate content for females who cannot get pregnant from the Guide for Female Patients.

5. Xyrem (sodium oxybate) REMS modified October 26, 2018 to update the REMS document and materials to align with labeling changes related to the new pediatric indication.

6.  Suboxone/Subutex (buprenorphine and naloxone/buprenorphine) REMS modified October 26, 2018 to align the REMS document and materials with the safety labeling changes approved on February 1, 2018. Those labeling changes pertained to the risks of life-threatening respiratory depression and death with concomitant use of buprenorphine with benzodiazepines or other CNS depressants, and additional revisions to the Package Insert.

7. Opioid Analgesic Shared System REMS added ANDA October 25, 2018, and ANDA October 30, 2018.

8.   Xiaflex (collagenase clostridium histolyticum) REMS revised October 30, 2018 to make minor editorial changes.

9.  Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) Shared System REMSmodified October 31, 2018 to align the REMS document and materials with the approved labeling. 

Those labeling changes pertained to the risks of life-threatening respiratory depression and death with concomitant use of buprenorphine with benzodiazepines or other CNS depressants, and additional revisions to the Package Insert.