Source facts
FDA issued an approval letter for ALECENSA on 2026-06-15. The source metadata identifies NDA 208434 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ALECENSA — FDA Approval Letter (NDA 208434)
Issued to HOFFMANN-LA ROCHE. Application is approved as submitted.
Issued
June 15, 2026Application
NDA 505b1 • 208434
Product
ALECENSA
Company
HOFFMANN-LA ROCHE
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ALECENSA?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 208434.
- 3Submission: supplement.
- 4Sponsor: HOFFMANN-LA ROCHE.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ALECENSA approval letter
Is ALECENSA FDA approved?
This letter documents an FDA approval action: FDA approved NDA 208434 for ALECENSA, sponsored by HOFFMANN-LA ROCHE, on June 15, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 208434?
NDA 208434 is the application under which FDA issued this approval letter for ALECENSA to HOFFMANN-LA ROCHE. The letter is dated June 15, 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.