Source facts
FDA issued an approval letter for SPRAVATO on 2026-06-26. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
SPRAVATO — FDA Approval Letter (NDA 211243)
Issued to JANSSEN PHARMS. Application is approved as submitted.
Issued
June 26, 2026Application
NDA 505b1 • 211243
Product
SPRAVATO
Company
JANSSEN PHARMS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for SPRAVATO?
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 211243.
- 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 SPRAVATO approval letter
Is SPRAVATO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 211243 for SPRAVATO, sponsored by JANSSEN PHARMS, on June 26, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 211243?
NDA 211243 is the application under which FDA issued this approval letter for SPRAVATO to JANSSEN PHARMS. The letter is dated June 26, 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.