Source facts
FDA issued an approval letter for BALOXAVIR MARBOXIL on 2026-06-18. The source metadata identifies ANDA 217449 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
BALOXAVIR MARBOXIL — FDA Approval Letter (ANDA 217449)
Issued to NORWICH. Application is approved as submitted.
Issued
June 18, 2026Application
ANDA 505j • 217449
Product
BALOXAVIR MARBOXIL
Company
NORWICH
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 217449.
- 3Submission: original application.
- 4Sponsor: NORWICH.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the BALOXAVIR MARBOXIL approval letter
Is BALOXAVIR MARBOXIL FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 217449 for BALOXAVIR MARBOXIL, sponsored by NORWICH, on June 18, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 217449?
ANDA 217449 is the application under which FDA issued this approval letter for BALOXAVIR MARBOXIL to NORWICH. The letter is dated June 18, 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.