Source facts
FDA issued an approval letter for AMONDYS 45 on 2026-01-08. The source metadata identifies NDA 213026 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
AMONDYS 45 — FDA Approval Letter (NDA 213026)
Issued to SAREPTA THERAPS INC. Application is approved as submitted.
Issued
January 8, 2026Application
NDA 505b1 • 213026
Product
AMONDYS 45
Company
SAREPTA THERAPS INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for AMONDYS 45?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 213026.
- 3Submission: supplement.
- 4Sponsor: SAREPTA THERAPS INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the AMONDYS 45 approval letter
Is AMONDYS 45 FDA approved?
This letter documents an FDA approval action: FDA approved NDA 213026 for AMONDYS 45, sponsored by SAREPTA THERAPS INC, on January 8, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 213026?
NDA 213026 is the application under which FDA issued this approval letter for AMONDYS 45 to SAREPTA THERAPS INC. The letter is dated January 8, 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.