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Nonrulemaking
FDA
Open for Comments
FDA-2025-P-3952
Requests that the FDA amend the labeling information for Toradol (oral) (ketorolac tromethamine tablets) to indicate that Toradol (oral) (ketorolac tromethamine tablets) is approved for use only in conjunction with a primary mode of therapy (postsurgical opioid analgesia or opioid analgesia if the FDA wishes to keep the indication for general acute pain).
Documents
3
Comments
1
Description
Open
Key Dates
Comment Period OpensSep 17, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Comment Statistics
Total Comments
1
Keywords
CDER
Citizen Petition
Requests that the FDA amend the labeling
information for Toradol (oral) (ketorolac
tromethamine tablets) to indicate that Toradol
(oral) (ketorolac tromethamine tablets) is
approved for use only in conjunction with a
primary mode of therapy (postsurgical opioid
Data from Regulations.gov