Source facts
FDA issued an approval letter for FOLLISTIM AQ on 2026-03-04. The source metadata identifies BLA 021211 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
FOLLISTIM AQ — FDA Approval Letter (BLA 021211)
Issued to ORGANON USA LLC. Application is approved as submitted.
Issued
March 4, 2026Application
BLA • 021211
Product
FOLLISTIM AQ
Company
ORGANON USA LLC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for FOLLISTIM AQ?
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 021211.
- 3Submission: supplement.
- 4Sponsor: ORGANON USA LLC.
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 FOLLISTIM AQ approval letter
Is FOLLISTIM AQ FDA approved?
This letter documents an FDA approval action: FDA approved BLA 021211 for FOLLISTIM AQ, sponsored by ORGANON USA LLC, on March 4, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 021211?
BLA 021211 is the application under which FDA issued this approval letter for FOLLISTIM AQ to ORGANON USA LLC. The letter is dated March 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.