Source facts
FDA issued an approval letter for DIVIGEL on 2026-02-12. The source metadata identifies NDA 022038 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DIVIGEL — FDA Approval Letter (NDA 022038)
Issued to VERTICAL PHARMS. Application is approved as submitted.
Issued
February 12, 2026Application
NDA 505b1 • 022038
Product
DIVIGEL
Company
VERTICAL PHARMS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DIVIGEL?
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 022038.
- 3Submission: supplement.
- 4Sponsor: VERTICAL PHARMS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the DIVIGEL approval letter
Is DIVIGEL FDA approved?
This letter documents an FDA approval action: FDA approved NDA 022038 for DIVIGEL, sponsored by VERTICAL PHARMS, on February 12, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 022038?
NDA 022038 is the application under which FDA issued this approval letter for DIVIGEL to VERTICAL PHARMS. The letter is dated February 12, 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.