Summary of REMS@FDA Website Updates for July and August, 2020

Summary of REMS@FDA Website Updates for July and August, 2020

1. Tysabri (natalizumab) REMS revised July 7, 2020 to make an editorial change.

2. Myalept (metreleptin) REMS modified July 13, 2020 to revise the “For Administration” section in the Prescription Authorization Form.

3. Gattex (teduglutide [rDNA origin]) REMS modified July 14, 200 to add a link to the healthcare provider survey on the Gattex REMS website.

4. Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) REMS modified July 17, 2020 to make minor modifications to the REMS Website that impact the Healthcare Settings (HCS) Enrollment Form and Prescriber Enrollment Form sections. The modifications will allow manual entry of the Health Care Setting Information and Prescriber Information in the required fields.

5. Xywav (calcium, magnesium, potassium, and sodium oxybates) and Xyrem (sodium oxybate) REMS modified July 21, 2020 to make changes to the REMS document, add an additional NDA number to include Xywav (NDA 212690),change the name of the REMS to the ‘Xywav and Xyrem REMS’, update the REMS Document to include Xywav. In addition, this REMS modification updates the format and content of the REMS Document consistent with the October 2017 Draft Guidance. Changes to the REMS materials to add an additional NDA to include Xywav (NDA 212690),addition of the following new REMS materials: Xywav REMS Prescription Form, Xywav REMS Patient Quick Start Guide, and Xywav REMS Brochure for Pediatric Patients and Their Caregivers.

6. Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) REMS modified July 24, 2020 due to the similar serious risks of CRS and neurological toxicities of YESCARTA and in order to minimize burden on the healthcare delivery system the REMS for YESCARTA and the REMS for TECARTUS have been merged into a single “YESCARTA and TECARTUS REMS” program.

7. Spravato (esketamine) REMS modified July 31, 2020 to change the requirements for the certified healthcare setting based on inpatient or outpatient setting in the REMS document; aligning the patient enrollment form, REMS website, and REMS Program Overview with these requirements; and replacing the single healthcare setting enrollment form with setting specific enrollment forms.

8. Turalio (pexidartinib) REMS modified August 4, 2020 to reflect changes to the REMS Prescriber Enrollment form, the Patient Enrollment form, and the REMS public web portal to allow the prescriber to delegate administrative REMS tasks, for the applicant to obtain additional information related to safety reports, to allow up to two additional certified prescribers to contribute to patient care and complete REMS documents, and to save REMS forms as pending while waiting for additional information.

9. Blenrep (belantamab mafodotin) REMS approved August 5, 2020.

10. Opioid Analgesic REMS added the following:

• Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate, ANDA 204649
• Levorphanol Tartrate, ANDA 213479
• Oxycodone and Aspirin, ANDA 040910

11. Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) REMS added ANDAs 206953 and 209069.

12. Mycophenolate Shared System REMS added ANDA 212087.