90 FR 125 pg. 29022 - Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correction
Type: NOTICEVolume: 90Number: 125Page: 29022
Page: 29022Docket number: [Docket Nos. FDA-2024-E-0209 and FDA-2024-E-0210]
FR document: [FR Doc. 2025-12343 Filed 7-1-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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]
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