Source facts
FDA issued an approval letter for SILIQ on 2026-03-03. The source metadata identifies BLA 761032 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
SILIQ — FDA Approval Letter (BLA 761032)
Issued to VALEANT LUXEMBOURG. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for SILIQ?
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Key details in this letter
- 1FDA action: approval.
- 2Application: BLA 761032.
- 3Submission: supplement.
- 4Sponsor: VALEANT LUXEMBOURG.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the SILIQ approval letter
Is SILIQ FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761032 for SILIQ, sponsored by VALEANT LUXEMBOURG, on March 3, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761032?
BLA 761032 is the application under which FDA issued this approval letter for SILIQ to VALEANT LUXEMBOURG. The letter is dated March 3, 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.