Source facts
FDA issued an approval letter for CARAC on 2026-05-04. The source metadata identifies NDA 020985 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CARAC — FDA Approval Letter (NDA 020985)
Issued to EXTROVIS. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for CARAC?
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 020985.
- 3Submission: supplement.
- 4Sponsor: EXTROVIS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CARAC approval letter
Is CARAC FDA approved?
This letter documents an FDA approval action: FDA approved NDA 020985 for CARAC, sponsored by EXTROVIS, on May 4, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 020985?
NDA 020985 is the application under which FDA issued this approval letter for CARAC to EXTROVIS. The letter is dated May 4, 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.