Summary of REMS@FDA website updates for June and July, 2018

Summary of REMS@FDA website updates for June and July, 2018

1.  Suboxone/Subutex (buprenorphine and naloxone/buprenorphine) REMS

modified June 11, 2018 to include the authorized generic of Suboxone sublingual film.

2. Juxtapid (lomitapide) REMS  modified June 4, 2018 to:

• remove the option of emailing completed Patient-Prescriber Authorization Forms (PPAFs) for protection of patient information
• require patients reaching age 18 to sign a PPAF (previously signed by a parent)
• add language on the website to clarify the order of actions for prescriber participation in the REMS
• establish an all-electronic process for submission of the certificate of completion of training and knowledge assessment
• streamline the process for completion of the prescriber enrollment form (use of auto-completion of the form using prescriber information already submitted)
• add text to the REMS website requesting pharmacies to contact Aegerion before attempting to certify
• update font colors on REMS forms to enhance readability
• add clarifying language on the Prescription Authorization Form (PAF) regarding how to submit a prescription. 

Revised June 18, 2018 to make an editorial change.

3.  Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) Shared System REMSadded ANDA 207607, June 14, 2018.

4. Vigabatrin Shared System REMS added ANDA 210196, June 21, 2018.

5. Xiaflex (collagenase clostridium histolyticum) REMS revised July 10, 2018 to reflect a change in ownership.

6.  Emtricitabine/tenofovir disoproxil fumarate Shared System REMS revised July 10, 2018 to correct a typographical error.

7.  Soliris (eculizumab) REMS  July 25, 2018 m odified the REMS Program supporting document, Soliris REMS document, Prescriber Safety Brochure, REMS Dosing and Administration guide, and Prescriber Introductory Letter and Enrollment Form, and removal of the Medication Guide from the REMS.

8. Jynarque (tolvaptan) REMS modified July 30, 2018 to: update website screenshots of the Liver Adverse Events Reporting Form; update the Patient Enrollment Form to delete a checkbox and the following sentence: "By checking this box, I agree to be contacted by the manufacturer's patient support program which provides patient support for the purposes of reimbursement, financial assistance, prescription tracking, patient advocacy, and coordinating care as necessary."