Source facts
FDA issued an approval letter for RIMEGEPANT on 2026-01-13. The source metadata identifies ANDA 219399 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
RIMEGEPANT — FDA Approval Letter (ANDA 219399)
Issued to APOTEX CORP. Application is approved as submitted.
Issued
January 13, 2026Application
ANDA 505j • 219399
Product
RIMEGEPANT
Company
APOTEX CORP
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for RIMEGEPANT?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 219399.
- 3Submission: original application.
- 4Sponsor: APOTEX CORP.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the RIMEGEPANT approval letter
Is RIMEGEPANT FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 219399 for RIMEGEPANT, sponsored by APOTEX CORP, on January 13, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 219399?
ANDA 219399 is the application under which FDA issued this approval letter for RIMEGEPANT to APOTEX CORP. The letter is dated January 13, 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.