BLA 761108/S-021
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your submission(s), provide a highlighted or marked-up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy should provide appropriate annotations, including supplement number(s) and annual report date(s).
We request that the labeling approved today be available on your website within 10 days of receipt of this letter.
CARTON AND CONTAINER LABELING
Submit final printed carton and container labeling that are identical to the enclosed carton and container labeling, as soon as they are available, but no more than 30 days after they are printed. Please submit these labeling electronically according to the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. For administrative purposes, designate this submission “Final Printed Carton and Container Labeling for approved BLA 761108/S-021.” Approval of this submission by FDA is not required before the labeling is used.
We have completed our review of this supplemental application, as amended. It is approved effective on the date of this letter.
RISK EVALUATION AND MITIGATION STRATEGY (REMS) REQUIREMENTS
The REMS for Ultomiris (ravulizumab-cwvz) was originally approved on December 21, 2018, and the most recent REMS modification was approved on April 27, 2022. The REMS consists of a elements to assure safe use and a timetable for submission of assessments of the REMS.
Your proposed modifications to the REMS consists of changes to the REMS document to align with labeling and updated REMS materials to incorporate the revised logo capturing both intravenous and subcutaneous routes of administration.
Your proposed modified REMS, submitted on September 23, 2021, amended and appended to this letter, is approved.
The timetable for submission of assessments of the REMS remains the same as that approved on December 21, 2018.
There are no changes to the REMS assessment plan described in our December 2, 2021, letter.
We remind you that in addition to the REMS assessments submitted according to the timetable in the approved REMS, you must include an adequate rationale to support a proposed REMS modification for the addition, modification, or removal of any goal or element of the REMS, as described in section 505-1(g)(4) of the FDCA.
U.S. Food and Drug Administration
Silver Spring, MD 20993
www.fda.gov
Reference ID: 5019210
