Source facts
FDA issued an approval letter for ERLEADA on 2026-03-09. The source metadata identifies NDA 210951 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ERLEADA — FDA Approval Letter (NDA 210951)
Issued to JANSSEN BIOTECH. Application is approved as submitted.
Issued
March 9, 2026Application
NDA 505b1 • 210951
Product
ERLEADA
Company
JANSSEN BIOTECH
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ERLEADA?
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 210951.
- 3Submission: supplement.
- 4Sponsor: JANSSEN BIOTECH.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ERLEADA approval letter
Is ERLEADA FDA approved?
This letter documents an FDA approval action: FDA approved NDA 210951 for ERLEADA, sponsored by JANSSEN BIOTECH, on March 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 210951?
NDA 210951 is the application under which FDA issued this approval letter for ERLEADA to JANSSEN BIOTECH. The letter is dated March 9, 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.