|  - Clozapine Shared System REMS modified on November 10, 2021 to make changes to the hours of operations for the Clozapine REMS Contact Center.
- Clozapine Shared System REMS updated on November 15, 2021 to implement new requirements that were approved as part of the July 29, 2021 REMS modification approval.
- Mycophenolate Shared System REMS revised on November 16, 2021 to reflect editorial changes.
- Ultomiris (ravulizumab-cwvz) modified on November 23, 2021 to:
- Update the Prescriber Enrollment Form to remove the "Other (please specify):" from the Credentials Box and a change in font color from orange to blue to highlight the website address and email address.
- Change the Prescriber Safety Brochure to update the indication sentence for PNH to include pediatric (one month and older) patients.
- Update the copyright date on all REMS materials.
- Suboxone/Subutex (buprenorphine and naloxone/buprenorphine) revised on November 29, 2021 to make editorial changes.
- Transmucosal Immediate-Release Fentanyl (TIRF) Products Shared System REMS modified on December 3, 2021 to makes changes in order to narrow the number of annual outpatient pharmacy audits required, not to exceed 400 pharmacies. The REMS Document was updated to reflect that TIRF application holders must annually audit all certified outpatient pharmacies, or a maximum of 400, that have received at least one shipment of a TIRF medicine in the past 12 months.
- Blenrep (belantamab mafodotin) modified on December 7, 2021 to:
- Incorporate the revised validity time frame of authorization for patients to receive their next scheduled dose of Blenrep based on their ophthalmic examination date in the REMS Document
- Allow patients to provide verbal acknowledgement to enroll into the Blenrep REMS in the Patient Enrollment Form
- Add a data entry field for "dose ordered in mg/kg" and "actual dose administered" in the REMS Checklist
- Update to the portal to improve visibility of patient status and treatment history, granting delegates access to the online portal, allowing prescribers to add or remove delegates online, and editorial revisions on the Eye Care Professional Consult Request Form, Patient Enrollment Form, REMS Checklist and Education Program for both Prescribers and Healthcare Settings and Website screenshots.
- Xywav and Xyrem (calcium, magnesium, potassium, and sodium oxybates) Xywav and Xyrem (sodium oxybate) modified on December 9, 2021 to make changes to the dosing table structure on the Xywav Prescription Form to prevent confusion when the prescriber fills out the form.
- Isotretinoin iPLEDGE Shared System REMS updated on December 13, 2021 to implement new requirements that were approved as part of the October 8, 2021 REMS modification approval.
- Mycophenolate Shared System REMS added ANDA 214871 and NDA 050791.
- Opioid Analgesic REMS added ANDA 214928 and ANDA 201295.
General REMS Update: On December 17, 2021, FDA launched a new REMS Public Dashboard which is an interactive web-based tool that allows for analysis and visualization of the REMS data files. | | | |
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