Source facts
FDA issued an approval letter for HYMPAVZI on 2026-06-09. The source metadata identifies BLA 761369 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
HYMPAVZI — FDA Approval Letter (BLA 761369)
Issued to PFIZER INC. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for HYMPAVZI?
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Key details in this letter
- 1FDA action: approval.
- 2Application: BLA 761369.
- 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 HYMPAVZI approval letter
Is HYMPAVZI FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761369 for HYMPAVZI, sponsored by PFIZER INC, on June 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761369?
BLA 761369 is the application under which FDA issued this approval letter for HYMPAVZI to PFIZER INC. The letter is dated June 9, 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.