Summary of REMS@FDA Website Updates for September and October, 2019

Summary of REMS@FDA Website Updates for September and October, 2019

1. Vigabatrin Shared System REMS modified September 12, to make changes to the nonpublic REMS website screenshots for the inpatient pharmacy REMS verification process

2. Zulresso REMS modified September 30 to align language across REMS materials, add a field to collect a DEA number on the Healthcare Setting Enrollment Form and Pharmacy Enrollment Form (following scheduling of Zulresso), add a field to capture the scheduled infusion start date, and includes minor editorial changes.

3. Addyi REMS modified October 9 to remove the elements to assure safe use (ETASU) and implementation system, and include the Medication Guide as an element of the REMS.

4. Ultomiris REMS modified October 18 to reflect changes to the Prescriber Safety Brochure including adding the new indication.

5. Lemtrada REMS modified October 29 to make revisions to the REMS materials to reflect the revised Indications and Usage statement and to incorporate myocardial ischemia as a potential manifestation of infusion reactions associated with Lemtrada. In addition, the REMS materials were revised to reflect the labeling revision advising prescribers to educate patients that serious infusion reactions can occur at the time of infusion or within 48 hours after the last infusion.

6. Opioid Analgesic Shared System REMS added the following:

• Acetaminophen and Codeine Tablets, ANDA 212418
• Methadone Hydrochloride Oral Solution, ANDA 207537
• Oxycodone and Acetaminophen Tablets, ANDA 211708

7. Alosetron Shared System REMS added ANDA 211621.