Source facts
FDA issued an approval letter for HEPZATO on 2026-05-29. The source metadata identifies NDA 201848 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
HEPZATO — FDA Approval Letter (NDA 201848)
Issued to DELCATH SYSTEMS INC. Application is approved as submitted.
Issued
May 29, 2026Application
NDA 505b1 • 201848
Product
HEPZATO
Company
DELCATH SYSTEMS INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for HEPZATO?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 201848.
- 3Submission: supplement.
- 4Sponsor: DELCATH SYSTEMS INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the HEPZATO approval letter
Is HEPZATO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 201848 for HEPZATO, sponsored by DELCATH SYSTEMS INC, on May 29, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 201848?
NDA 201848 is the application under which FDA issued this approval letter for HEPZATO to DELCATH SYSTEMS INC. The letter is dated May 29, 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.