Source facts
FDA issued an approval letter for LUPRON on 2026-05-08. The source metadata identifies NDA 019010 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
LUPRON — FDA Approval Letter (NDA 019010)
Issued to ABBVIE ENDOCRINE INC. Application is approved as submitted.
Issued
May 8, 2026Application
NDA 505b1 • 019010
Product
LUPRON
Company
ABBVIE ENDOCRINE INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for LUPRON?
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 019010.
- 3Submission: supplement.
- 4Sponsor: ABBVIE ENDOCRINE INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the LUPRON approval letter
Is LUPRON FDA approved?
This letter documents an FDA approval action: FDA approved NDA 019010 for LUPRON, sponsored by ABBVIE ENDOCRINE INC, on May 8, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 019010?
NDA 019010 is the application under which FDA issued this approval letter for LUPRON to ABBVIE ENDOCRINE INC. The letter is dated May 8, 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.