Source facts
FDA issued an approval letter for REGLAN on 2026-02-10. The source metadata identifies NDA 017862 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
REGLAN — FDA Approval Letter (NDA 017862)
Issued to HIKMA. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for REGLAN?
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 017862.
- 3Submission: supplement.
- 4Sponsor: HIKMA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the REGLAN approval letter
Is REGLAN FDA approved?
This letter documents an FDA approval action: FDA approved NDA 017862 for REGLAN, sponsored by HIKMA, 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 017862?
NDA 017862 is the application under which FDA issued this approval letter for REGLAN to HIKMA. 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.