FDA · United States
ketorolac tromethamine — FDA regulatory status
ketorolac tromethamine (ACULAR LS) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- ACULAR LS
- Originator
- Amphastar France Pharmaceuticals
- Mechanism
- Cyclooxygenase inhibitor
- Target
- Cyclooxygenase
- Structured fields
- 8
Sponsor / originator context: Amphastar France Pharmaceuticals. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Cyclooxygenase inhibitor. Target: Cyclooxygenase. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 118 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 13406 | Phase 3 | Regeneron UK | NCT01482910 |
| 15161 | Phase 3 | Bayer HealthCare Animal | NCT01783886 |
| 15161 | Phase 3 | Regeneron UK | NCT01783886 |
| 2.0 mg intravitreal aflibercept | Phase 3 | Regeneron UK | NCT01627249 |
| 22153 | Phase 3 | Regeneron UK | NCT05850520 |
| 4D-150 IVT (3E10 vg/eye) | Phase 3 | 4D Molecular Therapeutics | NCT07064759 |
| 4D-150 IVT (3E10 vg/eye) | Phase 3 | 4D Molecular Therapeutics | NCT06864988 |
| 4D-150-C004 | Phase 3 | 4D Molecular Therapeutics | 2025-521349-25-00 |
| 700 µg Dexamethasone | Phase 3 | Allergan Pharmaceuticals International | NCT00168324 |
| 8 mg aflibercept (BAY 86-5321) (High Dose) | Phase 3 | Regeneron UK | NCT06422507 |
| APL-2 | Phase 3 | Anaxis Pharma | 2024-512945-18-00 |
| APL-2, Pegcetacoplan | Phase 3 | Genzyme Europe | NCT07214740 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12344842 | Compositions and methods for treating and preventing macular degeneration | US |
| 12116622 | Methods of associating genetic variants with a clinical outcome in patients suffering from age-related macular degeneration treated with anti-VEGF | US |
| 12097188 | Compositions and methods for the treatment of macular degeneration | US |
| 12084515 | Compositions and methods for treatment of diabetic macular edema | US |
| 11969401 | Compositions and methods for treating or limiting development of age-related macular degeneration | US |
| 11769597 | Methods of associating genetic variants with a clinical outcome in patients suffering from age-related macular degeneration treated with anti-VEGF | US |
| 11519020 | Methods of associating genetic variants with a clinical outcome in patients suffering from age-related macular degeneration treated with anti-VEGF | US |
| 11046785 | Compositions and methods for treatment of diabetic macular edema | US |
| 11040055 | Method of treating diabetic retinopathy or wet type adult macular degeneration | US |
| 10968278 | Compositions comprising IL6R antibodies for the treatment of uveitis and macular edema and methods of using same | US |
| 10905770 | Topical delivery of therapeutic agents using cell-penetrating peptides for the treatment of age-related macular degeneration and other eye diseases | US |
| 2020339710 | GLYCOPHOSPHOLIPID POLYMERIC NETWORK AND USE THEREOF | US |
Related hubs
FAQ
What is the FDA approval status of ketorolac tromethamine?
ketorolac tromethamine currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get ketorolac tromethamine regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to ketorolac tromethamine?
This spoke lists 118 published programs associated with ketorolac tromethamine in our pipeline index.