Overview
A glucocorticoid employed, usually as eye drops, in the treatment of allergic and inflammatory conditions of the eye. It has also been used topically in the treatment of various skin disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732)
Indication
For the ophthalmic treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
Associated Conditions
- Allergic Conjunctivitis (AC)
- Anterior chamber inflammation
- Inflammation
- Keratitis
- Ocular Inflammation
- Ocular bacterial infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/14 | Phase 4 | Completed | |||
2023/02/08 | Phase 4 | Not yet recruiting | |||
2022/10/20 | Phase 4 | Not yet recruiting | |||
2022/04/06 | N/A | UNKNOWN | |||
2020/05/06 | Phase 4 | Completed | Military Hospital of Tunis | ||
2019/11/04 | Phase 3 | Completed | |||
2018/11/20 | Phase 4 | UNKNOWN | |||
2016/06/29 | Phase 4 | Completed | |||
2014/01/31 | Phase 3 | Completed | Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA | ||
2014/01/09 | Phase 2 | UNKNOWN | United States Naval Medical Center, San Diego |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Amneal Pharmaceuticals NY LLC | 60219-1586 | OPHTHALMIC | 1 mg in 1 mL | 1/11/2024 | |
| Allergan, Inc. | 11980-228 | OPHTHALMIC | 2.5 mg in 1 mL | 12/19/2023 | |
| Allergan, Inc. | 11980-211 | OPHTHALMIC | 1 mg in 1 mL | 12/20/2023 | |
| Eyevance Pharmaceuticals | 71776-100 | OPHTHALMIC | 1 mg in 1 mL | 10/10/2023 | |
| Alcon Laboratories, Inc. | 0065-0096 | OPHTHALMIC | 1 mg in 1 mL | 12/15/2016 | |
| Amneal Pharmaceuticals NY LLC | 60219-1585 | OPHTHALMIC | 1 mg in 1 mL | 1/11/2024 | |
| Pacific Pharma, Inc. | 60758-880 | OPHTHALMIC | 1 mg in 1 mL | 11/13/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FML LIQUIFILM OPHTHALMIC SUSPENSION 0.1% | SIN04347P | SOLUTION | 1 mg/ml | 5/3/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fluorometholone Eye Drops | 国药准字HJ20140262 | 化学药品 | 眼用制剂 | 10/30/2023 | |
| Fluorometholone Eye Drops | 国药准字HJ20130754 | 化学药品 | 眼用制剂 | 8/29/2023 | |
| Fluorometholone Eye Drops | 国药准字HJ20181090 | 化学药品 | 滴眼剂 | 11/4/2022 | |
| Fluorometholone Eye Drops | 国药准字HJ20181091 | 化学药品 | 滴眼剂 | 11/4/2022 | |
| Fluorometholone Eye Drops | 国药准字HJ20181092 | 化学药品 | 滴眼剂 | 11/4/2022 | |
| Fluorometholone Eye Drops | 国药准字HJ20181093 | 化学药品 | 滴眼剂 | 11/4/2022 | |
| Fluorometholone Eye Drops | 国药准字H20010693 | 化学药品 | 滴眼剂 | 8/12/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TOLON EYE DROPS 0.1% | N/A | N/A | N/A | 9/11/2006 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FML fluorometholone 1mg/mL eye drops bottle | 23212 | Medicine | A | 10/14/1991 | |
| FLAREX Sterile Ophthalmic Suspension Bottle | 25278 | Medicine | A | 10/15/1991 |
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