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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 pain—D010149G89.18
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 edemaD0082691124—8
PainD010146EFO_0003843R52——31—4
Dry eye syndromesD015352H04.12—111—3
PseudophakiaD019591———112
Intravitreal injectionsD058449———1—1
PterygiumD011625H11.0———1—1
GlaucomaD005901EFO_0000516H40———1—1
Exfoliation syndromeD017889EFO_0004235———1—1
Show 3 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920EFO_0000400E08-E13——1——1
Allergic conjunctivitisD003233EFO_0007141H10.44——1——1
Postoperative complicationsD011183——1——1
Retinal diseasesD012164HP_0000479H35.9——1——1
Eye diseasesD005128EFO_0003966H44——1——1
Lens diseasesD007905HP_0000517H25-H28——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Macular degenerationD008268EFO_0001365H35.30—1———1
Familial exudative vitreoretinopathiesD000080345—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PresbyopiaD011305H52.42————2
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pathologic dilatationD004108————22
KeratoconusD007640EFO_0004223H18.6————22
RegenerationD012038————22
PapilledemaD010211EFO_1001074H35.81————11
MyopiaD009216H52.1————11
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
5742
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
Q5T7T8
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
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2,391 adverse events reported
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