Source facts
FDA issued an approval letter for GIMOTI on 2026-02-10. The source metadata identifies NDA 209388 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
GIMOTI — FDA Approval Letter (NDA 209388)
Issued to QOL MEDCL. Application is approved as submitted.
Issued
February 10, 2026Application
NDA 505b1 • 209388
Product
GIMOTI
Company
QOL MEDCL
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for GIMOTI?
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 209388.
- 3Submission: supplement.
- 4Sponsor: QOL MEDCL.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the GIMOTI approval letter
Is GIMOTI FDA approved?
This letter documents an FDA approval action: FDA approved NDA 209388 for GIMOTI, sponsored by QOL MEDCL, on February 10, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 209388?
NDA 209388 is the application under which FDA issued this approval letter for GIMOTI to QOL MEDCL. The letter is dated February 10, 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.