Source facts
FDA issued an approval letter for ZERBAXA on 2026-05-13. The source metadata identifies NDA 206829 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ZERBAXA — FDA Approval Letter (NDA 206829)
Issued to CUBIST PHARMS LLC. Application is approved as submitted.
Issued
May 13, 2026Application
NDA 505b1 • 206829
Product
ZERBAXA
Company
CUBIST PHARMS LLC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ZERBAXA?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 206829.
- 3Submission: supplement.
- 4Sponsor: CUBIST PHARMS LLC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ZERBAXA approval letter
Is ZERBAXA FDA approved?
This letter documents an FDA approval action: FDA approved NDA 206829 for ZERBAXA, sponsored by CUBIST PHARMS LLC, on May 13, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 206829?
NDA 206829 is the application under which FDA issued this approval letter for ZERBAXA to CUBIST PHARMS LLC. The letter is dated May 13, 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.