Source facts
FDA issued an approval letter for INVOKANA on 2026-06-05. The source metadata identifies NDA 204042 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
INVOKANA — FDA Approval Letter (NDA 204042)
Issued to JANSSEN PHARMS. Application is approved as submitted.
Issued
June 5, 2026Application
NDA 505b1 • 204042
Product
INVOKANA
Company
JANSSEN PHARMS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for INVOKANA?
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 204042.
- 3Submission: supplement.
- 4Sponsor: JANSSEN PHARMS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the INVOKANA approval letter
Is INVOKANA FDA approved?
This letter documents an FDA approval action: FDA approved NDA 204042 for INVOKANA, sponsored by JANSSEN PHARMS, on June 5, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 204042?
NDA 204042 is the application under which FDA issued this approval letter for INVOKANA to JANSSEN PHARMS. The letter is dated June 5, 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.