Source facts
FDA issued an approval letter for SIVEXTRO on 2026-03-03. The source metadata identifies NDA 205435, NDA 205436 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
SIVEXTRO — FDA Approval Letter (NDA 205435)
Issued to CUBIST PHARMS LLC. Application is approved as submitted.
Issued
March 3, 2026Application
NDA 505b1 • 205435
Product
SIVEXTRO
Company
CUBIST PHARMS LLC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for SIVEXTRO?
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.
- 2Applications: NDA 205435, NDA 205436.
- 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 SIVEXTRO approval letter
Is SIVEXTRO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 205435 for SIVEXTRO, sponsored by CUBIST PHARMS LLC, on March 3, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 205435?
NDA 205435 is the application under which FDA issued this approval letter for SIVEXTRO to CUBIST PHARMS LLC. The letter is dated March 3, 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.