Source facts
FDA issued an approval letter for ZEVTERA on 2026-06-30. The source metadata identifies NDA 218275 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ZEVTERA — FDA Approval Letter (NDA 218275)
Issued to ISTX. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for ZEVTERA?
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: NDA 218275.
- 3Submission: supplement.
- 4Sponsor: ISTX.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ZEVTERA approval letter
Is ZEVTERA FDA approved?
This letter documents an FDA approval action: FDA approved NDA 218275 for ZEVTERA, sponsored by ISTX, on June 30, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 218275?
NDA 218275 is the application under which FDA issued this approval letter for ZEVTERA to ISTX. The letter is dated June 30, 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.