Source facts
FDA issued an approval letter for LANGLARA on 2026-05-01. The source metadata identifies BLA 761412 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
LANGLARA — FDA Approval Letter (BLA 761412)
Issued to SUNSHINE LAKE PHARMA CO LTD. Application is approved as submitted.
Issued
May 1, 2026Application
BLA • 761412
Product
LANGLARA
Company
SUNSHINE LAKE PHARMA CO LTD
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for LANGLARA?
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: BLA 761412.
- 3Submission: original application.
- 4Sponsor: SUNSHINE LAKE PHARMA CO LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the LANGLARA approval letter
Is LANGLARA FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761412 for LANGLARA, sponsored by SUNSHINE LAKE PHARMA CO LTD, on May 1, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761412?
BLA 761412 is the application under which FDA issued this approval letter for LANGLARA to SUNSHINE LAKE PHARMA CO LTD. The letter is dated May 1, 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.