Source facts
FDA issued an approval letter for SIMTRIYO on 2026-07-28. The source metadata identifies NDA 218145 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
SIMTRIYO — FDA Approval Letter (NDA 218145)
Issued to OTSUKA PHARMACEUTICAL CO LTD. Application is approved as submitted.
Issued
July 28, 2026Application
NDA 505b1 • 218145
Product
SIMTRIYO
Company
OTSUKA PHARMACEUTICAL CO LTD
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for SIMTRIYO?
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 218145.
- 3Submission: original application.
- 4Sponsor: OTSUKA PHARMACEUTICAL CO LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the SIMTRIYO approval letter
Is SIMTRIYO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 218145 for SIMTRIYO, sponsored by OTSUKA PHARMACEUTICAL CO LTD, on July 28, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 218145?
NDA 218145 is the application under which FDA issued this approval letter for SIMTRIYO to OTSUKA PHARMACEUTICAL CO LTD. The letter is dated July 28, 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.