Notices. Notice; correction
247 words·~1 min read·
/register/2025/07/02/2025-12343·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2024-E-0209 and FDA-2024-E-0210] Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration
(FDA)is correcting a notice that appeared in the **Federal Register** on May 12, 2025. The document, entitled “Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO,” announced the determination of the regulatory review period for ELREXFIO (elranatamab-bcmm) for purposes of patent extension. The document was published with only one of two docket numbers. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Jack Dan, Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 240-402-6940. SUPPLEMENTARY INFORMATION: In the **Federal Register** of Monday, May 12, 2025 (90 FR 20177), in FR Doc. 2025-08256, the following corrections are made: 1. On page 20177, in the second column of the header of the document, “Docket No. FDA-2024-E-0210” is corrected to read “Docket Nos. FDA-2024-E-0209 and FDA-2024-E-0210.” 2. On page 20177, in the ADDRESSES section, in the third column under Written/Paper Submissions, in the second and third lines of the Instructions paragraph, “Docket No. FDA-2024-E-0210” is corrected to read “Docket Nos. FDA-2024-E-0209 and FDA-2024-E-0210.” Dated: June 26, 2025. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-12343 Filed 7-1-25; 8:45 am]