Source facts
FDA issued an approval letter for INQOVI on 2026-05-15. The source metadata identifies NDA 212576 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
INQOVI — FDA Approval Letter (NDA 212576)
Issued to TAIHO ONCOLOGY. Application is approved as submitted.
Issued
May 15, 2026Application
NDA 505b1 • 212576
Product
INQOVI
Company
TAIHO ONCOLOGY
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for INQOVI?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 212576.
- 3Submission: supplement.
- 4Sponsor: TAIHO ONCOLOGY.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the INQOVI approval letter
Is INQOVI FDA approved?
This letter documents an FDA approval action: FDA approved NDA 212576 for INQOVI, sponsored by TAIHO ONCOLOGY, on May 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 212576?
NDA 212576 is the application under which FDA issued this approval letter for INQOVI to TAIHO ONCOLOGY. The letter is dated May 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.