Source facts
FDA issued an approval letter for HEPCLUDEX on 2026-05-26. The source metadata identifies BLA 761468 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
HEPCLUDEX — FDA Approval Letter (BLA 761468)
Issued to GILEAD SCIENCES INC. Application is approved as submitted.
Issued
May 26, 2026Application
BLA • 761468
Product
HEPCLUDEX
Company
GILEAD SCIENCES INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for HEPCLUDEX?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: BLA 761468.
- 3Submission: original application.
- 4Sponsor: GILEAD SCIENCES INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the HEPCLUDEX approval letter
Is HEPCLUDEX FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761468 for HEPCLUDEX, sponsored by GILEAD SCIENCES INC, on May 26, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761468?
BLA 761468 is the application under which FDA issued this approval letter for HEPCLUDEX to GILEAD SCIENCES INC. The letter is dated May 26, 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.