Source facts
FDA issued an approval letter for LIFYORLI (COPACKAGED) on 2026-03-27. The source metadata identifies NDA 220641 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
LIFYORLI (COPACKAGED) — FDA Approval Letter (NDA 220641)
Issued to CORCEPT THERAP. Application is approved as submitted.
Issued
March 27, 2026Application
NDA 505b1 • 220641
Product
LIFYORLI (COPACKAGED)
Company
CORCEPT THERAP
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for LIFYORLI (COPACKAGED)?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 220641.
- 3Submission: original application.
- 4Sponsor: CORCEPT THERAP.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the LIFYORLI (COPACKAGED) approval letter
Is LIFYORLI (COPACKAGED) FDA approved?
This letter documents an FDA approval action: FDA approved NDA 220641 for LIFYORLI (COPACKAGED), sponsored by CORCEPT THERAP, on March 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 220641?
NDA 220641 is the application under which FDA issued this approval letter for LIFYORLI (COPACKAGED) to CORCEPT THERAP. The letter is dated March 27, 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.