Source facts
FDA issued an approval letter for LYBALVI on 2026-02-03. The source metadata identifies NDA 213378 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
LYBALVI — FDA Approval Letter (NDA 213378)
Issued to ALKERMES INC. Application is approved as submitted.
Issued
February 3, 2026Application
NDA 505b1 • 213378
Product
LYBALVI
Company
ALKERMES INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for LYBALVI?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 213378.
- 3Submission: supplement.
- 4Sponsor: ALKERMES INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the LYBALVI approval letter
Is LYBALVI FDA approved?
This letter documents an FDA approval action: FDA approved NDA 213378 for LYBALVI, sponsored by ALKERMES INC, on February 3, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 213378?
NDA 213378 is the application under which FDA issued this approval letter for LYBALVI to ALKERMES INC. The letter is dated February 3, 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.