Source facts
FDA issued an approval letter for CAPLYTA on 2026-04-27. The source metadata identifies NDA 209500 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CAPLYTA — FDA Approval Letter (NDA 209500)
Issued to INTRA-CELLULAR. Application is approved as submitted.
Issued
April 27, 2026Application
NDA 505b1 • 209500
Product
CAPLYTA
Company
INTRA-CELLULAR
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CAPLYTA?
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 209500.
- 3Submission: supplement.
- 4Sponsor: INTRA-CELLULAR.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CAPLYTA approval letter
Is CAPLYTA FDA approved?
This letter documents an FDA approval action: FDA approved NDA 209500 for CAPLYTA, sponsored by INTRA-CELLULAR, on April 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 209500?
NDA 209500 is the application under which FDA issued this approval letter for CAPLYTA to INTRA-CELLULAR. The letter is dated April 27, 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.