Source facts
FDA issued an approval letter for EVRYSDI on 2026-01-22. The source metadata identifies NDA 219285, NDA 213535 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
EVRYSDI — FDA Approval Letter (NDA 219285)
Issued to GENENTECH INC. Application is approved as submitted.
Issued
January 22, 2026Application
NDA 505b1 • 219285
Product
EVRYSDI
Company
GENENTECH INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for EVRYSDI?
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.
- 2Applications: NDA 219285, NDA 213535.
- 3Submission: supplement.
- 4Sponsor: GENENTECH INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Read the full FDA approval letter (PDF)
Loading document viewer…
Common questions about the EVRYSDI approval letter
Is EVRYSDI FDA approved?
This letter documents an FDA approval action: FDA approved NDA 219285 for EVRYSDI, sponsored by GENENTECH INC, on January 22, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 219285?
NDA 219285 is the application under which FDA issued this approval letter for EVRYSDI to GENENTECH INC. The letter is dated January 22, 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.