Source facts
FDA issued an approval letter for AWIQLI FLEXTOUCH on 2026-03-31. The source metadata identifies BLA 761326 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
AWIQLI FLEXTOUCH — FDA Approval Letter (BLA 761326)
Issued to NOVO NORDISK INC. Application is approved as submitted.
Issued
March 31, 2026Application
BLA • 761326
Product
AWIQLI FLEXTOUCH
Company
NOVO NORDISK INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for AWIQLI FLEXTOUCH?
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Key details in this letter
- 1FDA action: approval.
- 2Application: BLA 761326.
- 3Submission: original application.
- 4Sponsor: NOVO NORDISK INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the AWIQLI FLEXTOUCH approval letter
Is AWIQLI FLEXTOUCH FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761326 for AWIQLI FLEXTOUCH, sponsored by NOVO NORDISK INC, on March 31, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761326?
BLA 761326 is the application under which FDA issued this approval letter for AWIQLI FLEXTOUCH to NOVO NORDISK INC. The letter is dated March 31, 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.