Source facts
FDA issued an approval letter for MYQORZO on 2026-02-06. The source metadata identifies NDA 219083 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
MYQORZO — FDA Approval Letter (NDA 219083)
Issued to CYTOKINETICS. Application is approved as submitted.
Issued
February 6, 2026Application
NDA 505b1 • 219083
Product
MYQORZO
Company
CYTOKINETICS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for MYQORZO?
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 219083.
- 3Submission: supplement.
- 4Sponsor: CYTOKINETICS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the MYQORZO approval letter
Is MYQORZO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 219083 for MYQORZO, sponsored by CYTOKINETICS, on February 6, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 219083?
NDA 219083 is the application under which FDA issued this approval letter for MYQORZO to CYTOKINETICS. The letter is dated February 6, 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.