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

---
identifier: "/us/fr/2025-12343"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2025-12343"
section_name: "Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correction"
positive_law: false
currency: "2025-07-02"
last_updated: "2025-07-02"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2025-12343"
document_type: "notice"
publication_date: "2025-07-02"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "90 FR 29022"
fr_volume: 90
docket_ids:
  - "Docket Nos. FDA-2024-E-0209 and FDA-2024-E-0210"
fr_action: "Notice; correction."
---


#  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.