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Xibrom, Yellox(bromfenac)
Bromsite, Prolensa, Yellox (bromfenac) is a small molecule pharmaceutical. Bromfenac was first approved as Xibrom on 2005-03-24. It is used to treat eye pain, inflammation, and postoperative pain in the USA. It has been approved in Europe to treat ophthalmologic surgical procedures and postoperative pain. The pharmaceutical is active against prostaglandin G/H synthase 1.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
eye diseasesD005128
signs and symptoms pathological conditionsD013568
operative surgical proceduresD013514
Trade Name
FDA
EMA
Bromsite, Prolensa (generic drugs available since 2014-01-22, discontinued: Bromday, Xibrom)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bromfenac sodium
Tradename
Company
Number
Date
Products
PROLENSABausch Health CompaniesN-203168 RX2013-04-05
1 products, RLD, RS
BROMSITEsparcN-206911 RX2016-04-08
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bromdayNew Drug Application2010-09-14
bromsiteNew Drug Application2019-01-25
prolensaNew Drug Application2020-04-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
eye painHP_0200026D058447H57.1
inflammationMP_0001845D007249
postoperative painD010149G89.18
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Bromfenac Sodium, Prolensa, Bausch And Lomb
95172202033-11-11U-1933
100859582032-11-19DP
81294312025-09-11DS, DP
86692902024-01-16DP
87541312024-01-16DP
88718132024-01-16DP
89276062024-01-16U-100, U-810, U-1095
91446092024-01-16DP
95612772024-01-16U-1933
Bromfenac Sodium, Bromsite, Sun Pharm
87789992029-08-07DPU-1834
ATC Codes
S: Sensory organ drugs
S01: Ophthalmologicals
S01B: Antiinflammatory agents, ophthalmologic
S01BC: Antiinflammatory agents, non-steroidal, ophthalmologic
S01BC11: Bromfenac
HCPCS
No data
Clinical
Clinical Trials
55 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CataractD002386EFO_0001059H26.91169219
InflammationD0072492163112
Macular edemaD00826911248
PainD010146EFO_0003843R52314
Dry eye syndromesD015352H04.121113
PseudophakiaD019591112
Intravitreal injectionsD05844911
PterygiumD011625H11.011
GlaucomaD005901EFO_0000516H4011
Exfoliation syndromeD017889EFO_000423511
Show 3 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920EFO_0000400E08-E1311
Allergic conjunctivitisD003233EFO_0007141H10.4411
Postoperative complicationsD01118311
Retinal diseasesD012164HP_0000479H35.911
Eye diseasesD005128EFO_0003966H4411
Lens diseasesD007905HP_0000517H25-H2811
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Macular degenerationD008268EFO_0001365H35.3011
Familial exudative vitreoretinopathiesD00008034511
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PresbyopiaD011305H52.422
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pathologic dilatationD00410822
KeratoconusD007640EFO_0004223H18.622
RegenerationD01203822
PapilledemaD010211EFO_1001074H35.8111
MyopiaD009216H52.111
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBROMFENAC
INNbromfenac
Description
Bromfenac is amfenac in which the the hydrogen at the 4 position of the benzoyl group is substituted by bromine. It is used for the management of ocular pain and treatment of postoperative inflammation in patients who have undergone cataract extraction. It was withdrawn from the US market in 1998, following concerns over off-label abuse and hepatic failure. It has a role as a non-steroidal anti-inflammatory drug and a non-narcotic analgesic. It is a member of benzophenones, a substituted aniline, an aromatic amino acid and an organobromine compound. It is functionally related to an amfenac. It is a conjugate acid of a bromfenac(1-).
Classification
Small molecule
Drug classanti-inflammatory agents (acetic acid derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1
Identifiers
PDB4MJQ
CAS-ID91714-94-2
RxCUI19737
ChEMBL IDCHEMBL1077
ChEBI ID240107
PubChem CID60726
DrugBankDB00963
UNII ID864P0921DW (ChemIDplus, GSRS)
Target
Agency Approved
PTGS1
PTGS1
Organism
Homo sapiens
Gene name
PTGS1
Gene synonyms
COX1
NCBI Gene ID
Protein name
prostaglandin G/H synthase 1
Protein synonyms
COX-1, Cyclooxygenase-1, PGH synthase 1, PGHS-1, PHS 1, Prostaglandin H2 synthase 1, Prostaglandin-endoperoxide synthase 1, prostaglandin-endoperoxide synthase 1 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Mouse ortholog
Ptgs1 (19224)
prostaglandin G/H synthase 1 (P22437)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 851 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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2,391 adverse events reported
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