Summary of REMS@FDA Website Updates for January and February, 2020

1. Suboxone/Subutex REMS revised January 24 to reflect editorial changes.

2. Isotretinoin iPLEDGE REMS modified January 24 to make changes to the Medication Guide, an element of the iPLEDGE REMS. This modification does not provide for any changes to the REMS document, appended materials, or REMS supporting document.

3. Vigabatrin Shared System REMS modified January 24 to make changes to the REMS materials to reflect the revised age range for the rCPS indication. The Prescriber Enrollment and Agreement Form, Patient Guide, and REMS Website have been revised to align with the revised age range for the rCPS indication.

4. Sublocade REMS revised January 28 to make an editorial change.  

5.  Palforzia REMS approved January 31.  

6. Adempas REMS modified February 10 to make changes to the prescriber and patient enrollment forms for consistency and clarity.

7. Blincyto REMS revised February 14 to make an editorial change.

8. Opioid Analgesic REMS added the following:

• hydrocodone bitartrate and acetaminophen ANDAs 211729 and 211690
• hydrocodone bitartrate ANDA 206986

9. Bosentan Shared System REMS added ANDAs 210342, 205173 and 211461.