Source facts
FDA issued an approval letter for XTORO on 2026-03-20. The source metadata identifies NDA 206307 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
XTORO — FDA Approval Letter (NDA 206307)
Issued to FONSECA BIOSCIENCES. Application is approved as submitted.
Issued
March 20, 2026Application
NDA 505b1 • 206307
Product
XTORO
Company
FONSECA BIOSCIENCES
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for XTORO?
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 206307.
- 3Submission: supplement.
- 4Sponsor: FONSECA BIOSCIENCES.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the XTORO approval letter
Is XTORO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 206307 for XTORO, sponsored by FONSECA BIOSCIENCES, on March 20, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 206307?
NDA 206307 is the application under which FDA issued this approval letter for XTORO to FONSECA BIOSCIENCES. The letter is dated March 20, 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.