Source facts
FDA issued an approval letter for SDAMLO on 2026-05-11. The source metadata identifies NDA 219531 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
SDAMLO — FDA Approval Letter (NDA 219531)
Issued to BRILLIAN PHARMA. Application is approved as submitted.
Issued
May 11, 2026Application
NDA 505b1 • 219531
Product
SDAMLO
Company
BRILLIAN PHARMA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for SDAMLO?
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 219531.
- 3Submission: supplement.
- 4Sponsor: BRILLIAN PHARMA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the SDAMLO approval letter
Is SDAMLO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 219531 for SDAMLO, sponsored by BRILLIAN PHARMA, on May 11, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 219531?
NDA 219531 is the application under which FDA issued this approval letter for SDAMLO to BRILLIAN PHARMA. The letter is dated May 11, 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.