Source facts
FDA issued an approval letter for ELREXFIO on 2026-03-27. The source metadata identifies BLA 761345 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ELREXFIO — FDA Approval Letter (BLA 761345)
Issued to PFIZER INC. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for ELREXFIO?
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Key details in this letter
- 1FDA action: approval.
- 2Application: BLA 761345.
- 3Submission: supplement.
- 4Sponsor: PFIZER INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ELREXFIO approval letter
Is ELREXFIO FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761345 for ELREXFIO, sponsored by PFIZER INC, on March 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761345?
BLA 761345 is the application under which FDA issued this approval letter for ELREXFIO to PFIZER INC. The letter is dated March 27, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.