thefederalregister.org Federal Register Research Archive

Document

Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correction

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 P...

PDF versionSource Record
Department of Health and Human Services
Food and Drug Administration
  1. [Docket Nos. FDA-2024-E-0209 and FDA-2024-E-0210]

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]

BILLING CODE 4164-01-P

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

90 FR 29022

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correction,” thefederalregister.org (July 2, 2025), https://thefederalregister.org/documents/2025-12343/determination-of-regulatory-review-period-for-purposes-of-patent-extension-elrexfio-correction.