Source facts
FDA issued an approval letter for LICART on 2026-03-31. The source metadata identifies NDA 206976 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
LICART — FDA Approval Letter (NDA 206976)
Issued to IBSA INST BIO. Application is approved as submitted.
Issued
March 31, 2026Application
NDA 505b1 • 206976
Product
LICART
Company
IBSA INST BIO
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for LICART?
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 206976.
- 3Submission: supplement.
- 4Sponsor: IBSA INST BIO.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the LICART approval letter
Is LICART FDA approved?
This letter documents an FDA approval action: FDA approved NDA 206976 for LICART, sponsored by IBSA INST BIO, on March 31, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 206976?
NDA 206976 is the application under which FDA issued this approval letter for LICART to IBSA INST BIO. The letter is dated March 31, 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.