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Drug ReportsFluorometholone
Fluorometholone
Flarex, Fluorometholone, Fml, Fml-s, Tobrasone (fluorometholone) is a small molecule pharmaceutical. Fluorometholone was first approved as Oxylone on 1982-01-01. It is used to treat conjunctivitis, inflammation, and keratitis in the USA. The pharmaceutical is active against glucocorticoid receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
eye diseasesD005128
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Flarex, Fluorometholone, Fml (discontinued: Fluor-op, Fml, Oxylone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluorometholone
Tradename
Company
Number
Date
Products
FMLAbbVieN-016851 RX1982-07-28
1 products, RLD, RS
FML FORTEAbbVieN-019216 RX1986-04-23
1 products, RLD, RS
Show 2 discontinued
Fluorometholone
+
Sulfacetamide sodium
Tradename
Company
Number
Date
Products
FML-SAllerganN-019525 DISCN1989-09-29
1 products
Hide discontinued
Fluorometholone acetate
Tradename
Company
Number
Date
Products
FLAREXHarrowN-019079 RX1986-02-11
1 products, RLD, RS
Fluorometholone acetate
+
Tobramycin
Tradename
Company
Number
Date
Products
TOBRASONEHarrowN-050628 DISCN1989-07-21
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
flarexNew Drug Application2025-03-31
fluorometholoneNDA authorized generic2020-09-24
fluorometholone ophthalmic suspensionANDA2024-01-09
fmlNew Drug Application2023-12-15
fml forteNew Drug Application2025-02-13
fml-s2007-02-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
inflammationMP_0001845D007249—
keratitis—D007634H16
conjunctivitis—D003231H10
corneal ulcer—D003320H16.0
bacterial infections—D001424A49
bacterial skin diseases—D017192—
trachoma—D014141A71
ear diseasesEFO_1001455D004427H93.9
seborrheic dermatitis—D012628L21
respiratory tract infections—D012141J06.9
Show 8 more
Agency Specific
FDA
EMA
Expiration
Code
FLUOROMETHOLONE, FLUOROMETHOLONE, AMNEAL
2024-07-07CGT
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AA: Corticosteroids, topical for treatment of hemorrhoids and anal fissures
— C05AA06: Fluorometholone
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AB: Corticosteroids, moderately potent (group ii)
— D07AB06: Fluorometholone
— D07C: Corticosteroids, combinations with antibiotics
— D07CB: Corticosteroids, moderately potent, combinations with antibiotics
— D07CB03: Fluorometholone and antibiotics
— D07X: Corticosteroids, other combinations
— D07XB: Corticosteroids, moderately potent, other combinations
— D07XB04: Fluorometholone
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AA: Corticosteroids, combinations for treatment of acne
— D10AA01: Fluorometholone
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
— S01BA07: Fluorometholone
— S01BB: Corticosteroids and mydriatics in combination
— S01BB03: Fluorometholone and mydriatics
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA07: Fluorometholone and antiinfectives
— S01CB: Corticosteroids/antiinfectives/mydriatics in combination
— S01CB05: Fluorometholone
HCPCS
No data
Clinical
Clinical Trials
34 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lacrimal apparatus diseasesD007766—H04—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFluorometholone
INNfluorometholone
Description
Fluorometholone is a member of the class of glucocorticoids that is Delta(1)-progesterone substituted at positions 11beta and 17 by hydroxy groups, at position 6alpha by a methyl group and at position 9 by a fluoro group. Used for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. It has a role as an anti-inflammatory drug. It is a fluorinated steroid, an 11beta-hydroxy steroid, a 20-oxo steroid, a 3-oxo-Delta(1),Delta(4)-steroid, a glucocorticoid, a 17alpha-hydroxy steroid and a tertiary alpha-hydroxy ketone. It is functionally related to a Delta(1)-progesterone.
Classification
Small molecule
Drug classsteroids (not prednisolone derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(=O)[C@@]1(O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@@]21C
Identifiers
PDB—
CAS-ID426-13-1
RxCUI—
ChEMBL IDCHEMBL1200600
ChEBI ID31625
PubChem CID9878
DrugBankDB00324
UNII IDSV0CSG527L (ChemIDplus, GSRS)
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
2908
Protein name
glucocorticoid receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)
Uniprot ID
Q6N0A4
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Fluorometholone
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,341 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,184 adverse events reported
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