Source facts
FDA issued an approval letter for ROXYBOND on 2026-06-23. The source metadata identifies NDA 209777 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ROXYBOND — FDA Approval Letter (NDA 209777)
Issued to PROTEGA PHARMS. Application is approved as submitted.
Issued
June 23, 2026Application
NDA 505b1 • 209777
Product
ROXYBOND
Company
PROTEGA PHARMS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ROXYBOND?
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 209777.
- 3Submission: supplement.
- 4Sponsor: PROTEGA PHARMS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ROXYBOND approval letter
Is ROXYBOND FDA approved?
This letter documents an FDA approval action: FDA approved NDA 209777 for ROXYBOND, sponsored by PROTEGA PHARMS, on June 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 209777?
NDA 209777 is the application under which FDA issued this approval letter for ROXYBOND to PROTEGA PHARMS. The letter is dated June 23, 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.