Source facts
FDA issued an approval letter for LAZCLUZE on 2026-05-04. The source metadata identifies NDA 219008 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
LAZCLUZE — FDA Approval Letter (NDA 219008)
Issued to JANSSEN BIOTECH. Application is approved as submitted.
Issued
May 4, 2026Application
NDA 505b1 • 219008
Product
LAZCLUZE
Company
JANSSEN BIOTECH
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for LAZCLUZE?
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 219008.
- 3Submission: supplement.
- 4Sponsor: JANSSEN BIOTECH.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Read the full FDA approval letter (PDF)
Loading document viewer…
Common questions about the LAZCLUZE approval letter
Is LAZCLUZE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 219008 for LAZCLUZE, sponsored by JANSSEN BIOTECH, on May 4, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 219008?
NDA 219008 is the application under which FDA issued this approval letter for LAZCLUZE to JANSSEN BIOTECH. The letter is dated May 4, 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.