Summary of REMS@FDA Website Updates for November and December, 2019

Summary of REMS@FDA Website Updates for November and December, 2019

1. Sublocade REMS: revised November 7, 2019 to make an editorial change. 2. Clozapine Shared System REMS: revised November 12, 2019 to reflect editorial changes. 3. Yescarta REMS: modified November 12, 2019 to reflect minor revision to the Yescarta REMS Website requesting to report suspected serious adverse events associated with Yescarta. 4. Opioid Analgesic Shared System REMS: modified November 14, 2019 to add Medication Guides for authorized generics that are identical to that of the branded products (Oxycontin and Hysingla ER), except different distributors are listed for the authorized generics. Fentanyl transdermal system ANDA 077062 and ANDA 076709 withdrawn November 18, 2019. Levorphanol tablets, ANDA 212024 added December 13, 2019. 5. Turalio REMS: modified November 19, 2019 to reflect changes to the Patient Enrollment Form to clarify instructions and add additional fields. 6. Vigabatrin Shared System REMS: added vigabatrin for oral solution, ANDA 211592 on December 3, 2019. 7. Jynarque REMS: modified December 3, 2019 to update the Liver Adverse Events Reporting Form, Patient Status Form, Prescriber Training, Prescriber Enrollment Form, Patient Online Enrollment, and the Patient Enrollment Form, more specifically: Liver Adverse Events Reporting Form and Patient Status Form: Updated instructions, definitions, and criteria for serious liver event reporting Added patient and prescriber REMS ID Added space for general liver laboratory information Added a checkbox to indicate whether treatment was discontinued due to a liver event Added text indicating Otsuka will reach out for additional information on reported liver events Prescriber Training: Added definition for serious and potentially fatal liver injury Prescriber Enrollment Form: Added attestation that the prescriber will be contacted for further information regarding reports of serious and potentially fatal liver injury Patient Online Enrollment: Updated patient online enrollment process Patient Enrollment Form: Added REMS Coordinating Center fax number 8. Extraneal REMS: released December 4, 2019. 9. Siliq REMS: revised December 13, 2019 to reflect editorial changes. 10. Zulresso REMS: modified December 13, 2019 to revise language in the REMS document and materials to allow for online capabilities for enrollment, verification, training, and submission of both the Post Infusion Form and the Excessive Sedation and Loss of Consciousness Adverse Event Form, added a field on the Post Infusion Form to collect the reason why an enrolled patient did not receive Zulresso, revised language in the REMS document to specify that certified healthcare settings and certified pharmacies will be audited no later than 90 calendar days after they have placed the first order rather than after certification, and minor editorial changes throughout the REMS materials. 11. Alvimopan Shared System REMS: approved December 19, 2019.