Source facts
FDA issued an approval letter for PYRUKYND, AQVESME on 2026-06-23. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
PYRUKYND / AQVESME — FDA Approval Letter (NDA 216196)
Issued to AGIOS PHARMS INC. Application is approved as submitted.
Issued
June 23, 2026Application
NDA 505b1 • 216196
Product
PYRUKYND / AQVESME
Company
AGIOS PHARMS INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for PYRUKYND / AQVESME?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 216196.
- 3Submission: supplement.
- 4Sponsor: AGIOS PHARMS INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the PYRUKYND / AQVESME approval letter
Is PYRUKYND / AQVESME FDA approved?
This letter documents an FDA approval action: FDA approved NDA 216196 for PYRUKYND / AQVESME, sponsored by AGIOS PHARMS INC, on June 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 216196?
NDA 216196 is the application under which FDA issued this approval letter for PYRUKYND / AQVESME to AGIOS PHARMS INC. The letter is dated June 23, 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.