Source facts
FDA issued an approval letter for BINOSTO on 2026-02-05. The source metadata identifies NDA 202344 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
BINOSTO — FDA Approval Letter (NDA 202344)
Issued to RADIUS. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for BINOSTO?
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 202344.
- 3Submission: supplement.
- 4Sponsor: RADIUS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the BINOSTO approval letter
Is BINOSTO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 202344 for BINOSTO, sponsored by RADIUS, on February 5, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 202344?
NDA 202344 is the application under which FDA issued this approval letter for BINOSTO to RADIUS. The letter is dated February 5, 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.