Source facts
FDA issued a tentative approval letter for RIFAXIMIN on 2026-02-11. The source metadata identifies ANDA 219687 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordTA · Tentative Approval Letter
RIFAXIMIN — FDA Tentative Approval Letter (ANDA 219687)
Issued to MYLAN PHARMACEUTICALS INC. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
February 11, 2026Application
ANDA 505j • 219687
Product
RIFAXIMIN
Company
MYLAN PHARMACEUTICALS INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for RIFAXIMIN?
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: tentative approval.
- 2Application: ANDA 219687.
- 3Submission: original application.
- 4Sponsor: MYLAN PHARMACEUTICALS INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the RIFAXIMIN tentative approval letter
Is RIFAXIMIN FDA approved?
Not for marketing yet. FDA granted tentative approval to ANDA 219687 for RIFAXIMIN on February 11, 2026, meaning the application meets approval standards but patent or exclusivity protections block final approval. The product cannot be marketed until those conditions resolve and FDA issues final approval.
What is ANDA 219687?
ANDA 219687 is the application under which FDA issued this tentative approval letter for RIFAXIMIN to MYLAN PHARMACEUTICALS INC. The letter is dated February 11, 2026.
What happens after an FDA tentative approval letter?
The product cannot be marketed yet. Tentative approval means the application meets FDA approval standards, but patent or exclusivity protections block final approval. The sponsor typically requests final approval as the blocking date approaches, and FDA re-verifies that the approval conditions still hold before granting it.