{"id":"fluorometholone-acetate","rwe":[],"_fda":{"id":"2bed0334-e39e-c18b-e063-6294a90af598","set_id":"19918ea5-8568-44d6-b8ee-7b2197cee85c","openfda":{"upc":["0371776100059","0371776100035"],"unii":["9I50C3I3OK"],"route":["OPHTHALMIC"],"rxcui":["1249629","1249631"],"spl_id":["2bed0334-e39e-c18b-e063-6294a90af598"],"brand_name":["Flarex"],"spl_set_id":["19918ea5-8568-44d6-b8ee-7b2197cee85c"],"package_ndc":["71776-100-05","71776-100-03"],"product_ndc":["71776-100"],"generic_name":["FLUOROMETHOLONE ACETATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["FLUOROMETHOLONE ACETATE"],"manufacturer_name":["Eyevance Pharmaceuticals"],"application_number":["NDA019079"],"is_original_packager":[true]},"version":"7","warnings":["WARNINGS FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION. Use in the treatment of herpes simplex infection requires great caution. Prolonged use may result in glaucoma, damage to the optic nerve, defect in visual acuity and visual field, cataract formation and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host response. Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication. Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids. If these products are used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients."],"pregnancy":["Pregnancy Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."],"description":["DESCRIPTION FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1% is a corticosteroid prepared as a sterile topical ophthalmic suspension. The active ingredient, fluorometholone acetate, is a white to creamy white powder with an empirical formula of C 24 H 31 FO 5 and a molecular weight of 418.5. Its chemical name is 9-fluoro-11β, 17-dihydroxy-6α-methylpregna-1, 4-diene-3, 20-dione 17-acetate. The chemical structure of Fluorometholone Acetate is presented below: Each mL of FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% contains: Active: fluorometholone acetate 1 mg (0.1%). Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, monobasic sodium phosphate, edetate disodium, hydroxyethyl cellulose, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water. The pH of the suspension is approximately 7.3, with an osmolality of approximately 300 mOsm/kg. Chemical Structure"],"precautions":["PRECAUTIONS General Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Prescription Guidelines The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation. Information for Patients Do not touch dropper tip to any surface, as this may contaminate the suspension. The preservative in FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1%, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% but may be reinserted 15 minutes after instillation. Patients should be advised that their vision may be temporarily blurred following dosing with FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1%. Care should be exercised in operating machinery or driving a motor vehicle. Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone. Pregnancy Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLAREX (fluorometholone acetate ophthalmic suspension) 0.1%, is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients."],"how_supplied":["HOW SUPPLIED FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is supplied in white low density polyethylene (LDPE) bottles, with natural LDPE dispensing plugs and pink polypropylene closures. The product is supplied as 5 mL in an 8 mL bottle. 5 mL: NDC 71776-100-05 STORAGE Store upright between 2°C to 25°C (36°F to 77°F). After opening, FLAREX can be used until the expiration date on the bottle. Protect from freezing."],"geriatric_use":["Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients."],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"effective_time":"20250117","nursing_mothers":["Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLAREX (fluorometholone acetate ophthalmic suspension) 0.1%, is administered to a nursing woman."],"adverse_reactions":["ADVERSE REACTIONS Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur. Postmarketing Experience The following reaction has been identified during post-marketing use of FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1% in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes: dysgeusia. The following rare adverse reactions have been reported: Cushing's syndrome and adrenal suppression may occur after very frequent use of topical ophthalmic corticosteroids, particularly in very young children."],"contraindications":["CONTRAINDICATIONS Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation."],"how_supplied_table":["<table width=\"85%\" styleCode=\"Noautorules\"><colgroup><col align=\"left\" valign=\"top\" width=\"50%\"/><col align=\"left\" valign=\"top\" width=\"50%\"/></colgroup><tbody><tr><td>5 mL:</td><td>NDC 71776-100-05</td></tr><tr><td/><td/></tr></tbody></table>"],"general_precautions":["General Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use."],"teratogenic_effects":["Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."],"storage_and_handling":["STORAGE Store upright between 2°C to 25°C (36°F to 77°F). After opening, FLAREX can be used until the expiration date on the bottle. Protect from freezing."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Corticosteroids suppress the inflammatory response to inciting agents of mechanical, chemical or immunological nature. No generally accepted explanation of this steroid property has been advanced. Corticosteroids cause a rise in intraocular pressure (IOP) in susceptible individuals. In a small study, FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% demonstrated a significantly longer average time to produce a rise in IOP than did dexamethasone phosphate; however, the ultimate magnitude of the rise was equivalent for both drugs and in a small percentage of individuals a significant rise in IOP occurred within three days."],"indications_and_usage":["INDICATIONS AND USAGE FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye."],"information_for_patients":["Information for Patients Do not touch dropper tip to any surface, as this may contaminate the suspension. The preservative in FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1%, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% but may be reinserted 15 minutes after instillation. Patients should be advised that their vision may be temporarily blurred following dosing with FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1%. Care should be exercised in operating machinery or driving a motor vehicle."],"spl_unclassified_section":["Manufactured for: Eyevance Pharmaceuticals, LLC Fort Worth, TX 76102 USA Revised: 7/2022"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Shake Well Before Using. One to two drops instilled into the conjunctival sac(s) four times daily. During the initial 24 to 48 hours the dosage may be safely increased to two drops every two hours. If no improvement after two weeks, consult physician. Care should be taken not to discontinue therapy prematurely. Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation [see PRECAUTIONS ] ."],"spl_product_data_elements":["Flarex fluorometholone acetate BENZALKONIUM CHLORIDE SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM EDETATE DISODIUM HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) TYLOXAPOL HYDROCHLORIC ACID SODIUM HYDROXIDE WATER FLUOROMETHOLONE ACETATE FLUOROMETHOLONE"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 2.5 mL Bottle Carton Sample - Not for Sale eyevance ® pharmaceuticals Flarex ® (fluorometholone acetate ophthalmic suspension) 0.1 % FOR TOPICAL OPHTHALMIC USE 2.5mL Sterile 2.5 mL PRINCIPAL DISPLAY PANEL - 2.5 mL Bottle Carton","PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton eyevance ™ pharmaceuticals Flarex ® (fluorometholone acetate ophthalmic suspension) 0.1 % FOR TOPICAL OPHTHALMIC USE 5 mL Sterile 5 mL PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone."]},"tags":[{"label":"Corticosteroid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Glucocorticoid receptor","category":"target"},{"label":"NR3C1","category":"gene"},{"label":"Ophthalmic","category":"route"},{"label":"Suspension/ Drops","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Allergic conjunctivitis","category":"indication"},{"label":"Corneal abrasion","category":"indication"},{"label":"Corneal ulcer","category":"indication"},{"label":"Cyclitis","category":"indication"},{"label":"Herpes zoster keratitis","category":"indication"},{"label":"Iridocyclitis","category":"indication"},{"label":"Harrow Eye","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Anti-Allergic Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents","category":"pharmacology"},{"label":"Glucocorticoids","category":"pharmacology"},{"label":"Hormones","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"EYE PAIN","source":"FDA FAERS","actionTaken":"60 reports"},{"date":"","signal":"EYE IRRITATION","source":"FDA FAERS","actionTaken":"26 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"21 reports"},{"date":"","signal":"VISION BLURRED","source":"FDA FAERS","actionTaken":"21 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"19 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"18 reports"},{"date":"","signal":"OCULAR HYPERAEMIA","source":"FDA FAERS","actionTaken":"18 reports"},{"date":"","signal":"PRODUCT DOSE OMISSION ISSUE","source":"FDA FAERS","actionTaken":"17 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"PHOTOPHOBIA","source":"FDA FAERS","actionTaken":"15 reports"}],"commonSideEffects":[{"effect":"Glaucoma with optic nerve damage","drugRate":"reported","severity":"unknown"},{"effect":"Visual acuity and field defects","drugRate":"reported","severity":"unknown"},{"effect":"Cataract formation","drugRate":"reported","severity":"unknown"},{"effect":"Secondary ocular infection following suppression of host response","drugRate":"reported","severity":"unknown"},{"effect":"Perforation of the globe","drugRate":"reported","severity":"unknown"},{"effect":"Dysgeusia","drugRate":"reported","severity":"unknown"}],"contraindications":["Bacterial infection of eye","Diabetes mellitus","Eye infection","Fungal infection of eye","Herpes simplex dendritic keratitis","Herpes simplex keratitis","Krukenberg spindle","Ocular hypertension","Open-angle glaucoma","Severe myopia","Tuberculosis of eye","Vaccinia keratitis","Viral eye infection"],"specialPopulations":{"Pregnancy":"Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well controlled studies of fluorom","Geriatric use":"No overall differences in safety or effectiveness have been observed between elderly and younger patients.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Harrow Health","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$15.4158/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$5,550","description":"FLUOROMETHOLONE 0.1% DROPS","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FLUOROMETHOLONE ACETATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:16:34.004734+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:16:41.291493+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:16:32.647941+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FLUOROMETHOLONE ACETATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:16:41.972383+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:16:31.180838+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:16:52.323746+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:16:31.180884+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:16:43.972660+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Glucocorticoid receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:16:43.043491+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201064/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:16:42.951438+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA019079","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:16:31.180891+00:00"}},"allNames":"flarex","offLabel":[],"synonyms":["fluorometholone acetate","oxylone acetate","eflone"],"timeline":[{"date":"1986-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ALCON to Harrow Eye"},{"date":"1986-02-11","type":"positive","source":"DrugCentral","milestone":"FDA approval (Alcon)"}],"aiSummary":"Flarex (fluorometholone acetate) is a corticosteroid medication originally developed by Alcon and currently owned by Harrow Eye. It targets the glucocorticoid receptor to reduce inflammation in the eye. Flarex is approved to treat various ocular conditions, including allergic conjunctivitis, corneal abrasions, and post-operative ocular inflammation. The medication is a small molecule corticosteroid that is off-patent, meaning it is no longer protected by active patents. As a result, there are currently no generic manufacturers of Flarex.","approvals":[{"date":"1986-02-11","orphan":false,"company":"ALCON","regulator":"FDA"}],"brandName":"Flarex","ecosystem":[{"indication":"Allergic conjunctivitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alcaftadine","slug":"alcaftadine","company":"Allergan"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Corneal abrasion","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"bacitracin","slug":"bacitracin","company":"Pharmacia And Upjohn"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""}],"globalPrevalence":null},{"indication":"Corneal ulcer","otherDrugs":[{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"fluorometholone","slug":"fluorometholone","company":"Allergan"},{"name":"hydrocortisone","slug":"hydrocortisone","company":"Merck"}],"globalPrevalence":null},{"indication":"Cyclitis","otherDrugs":[{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"fluorometholone","slug":"fluorometholone","company":"Allergan"},{"name":"hydrocortisone","slug":"hydrocortisone","company":"Merck"}],"globalPrevalence":40000},{"indication":"Herpes zoster keratitis","otherDrugs":[{"name":"cortisone 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Inflammation","otherDrugs":[{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"bromfenac","slug":"bromfenac","company":"Bausch And Lomb Inc"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Glucocorticoid receptor","novelty":"Follow-on","targets":[{"gene":"NR3C1","source":"DrugCentral","target":"Glucocorticoid receptor","protein":"Glucocorticoid receptor"}],"moaClass":"Corticosteroid Hormone Receptor Agonists","modality":"Small Molecule","drugClass":"Corticosteroid","explanation":"","oneSentence":"","technicalDetail":"Flarex (fluorometholone acetate) is a synthetic corticosteroid that exerts its anti-inflammatory effects by binding to the glucocorticoid receptor, which then translocates to the nucleus and regulates the expression of genes involved in inflammation."},"commercial":{"launchDate":"1986","_launchSource":"DrugCentral (FDA 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dipropionate","drugSlug":"alclometasone-dipropionate","fdaApproval":"1982-12-14","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"amcinonide","drugSlug":"amcinonide","fdaApproval":"1979-10-18","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"auranofin","drugSlug":"auranofin","fdaApproval":"1985-05-24","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"beclometasone dipropionate","drugSlug":"beclometasone-dipropionate","fdaApproval":"1976-05-12","relationship":"same-target"},{"drugName":"betamethasone","drugSlug":"betamethasone","fdaApproval":"1961-04-17","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"betamethasone acetate","drugSlug":"betamethasone-acetate","fdaApproval":"1965-03-03","relationship":"same-target"},{"drugName":"betamethasone 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conditions of the eye","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with the above conditions","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with the above conditions","diagnosticRequired":null,"brandNameForIndication":"Flarex"}],"offLabel":[{"name":"Allergic otitis externa","source":"DrugCentral","drugName":"FLUOROMETHOLONE ACETATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Otitis Externa Eczema","source":"DrugCentral","drugName":"FLUOROMETHOLONE ACETATE"},{"name":"Otitis Externa Seborrhea","source":"DrugCentral","drugName":"FLUOROMETHOLONE ACETATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Otitis externa","source":"DrugCentral","drugName":"FLUOROMETHOLONE ACETATE","evidenceCount":0,"evidenceLevel":"emerging"}],"pipeline":[]},"currentOwner":"Harrow Eye","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book 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