Source facts
FDA issued an approval letter for CAPRELSA on 2026-01-28. The source metadata identifies NDA 022405 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CAPRELSA — FDA Approval Letter (NDA 022405)
Issued to GENZYME CORP. Application is approved as submitted.
Issued
January 28, 2026Application
NDA 505b1 • 022405
Product
CAPRELSA
Company
GENZYME CORP
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CAPRELSA?
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 022405.
- 3Submission: supplement.
- 4Sponsor: GENZYME CORP.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CAPRELSA approval letter
Is CAPRELSA FDA approved?
This letter documents an FDA approval action: FDA approved NDA 022405 for CAPRELSA, sponsored by GENZYME CORP, on January 28, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 022405?
NDA 022405 is the application under which FDA issued this approval letter for CAPRELSA to GENZYME CORP. The letter is dated January 28, 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.