Wednesday, July 8, 2026

Drug profile · INN

ketotifen fumarate

ketotifen fumarate (KETOTIFEN FUMARATE) is a histamine h1 receptor antagonist. Associated with Essential Pharma Limited. Route of administration: ophthalmic. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 20
Pipeline programs 0
News articles 0
Drug details — ketotifen fumarate
US status
approved
Class
Route
OPHTHALMIC
Patents
20
Programs
0
Data quality
0.89

Quick answer

ketotifen fumarate (KETOTIFEN FUMARATE) is a histamine h1 receptor antagonist. Associated with Essential Pharma Limited. Route of administration: ophthalmic. Current US regulatory status: approved.

Key facts

INN ketotifen fumarate
Brand KETOTIFEN FUMARATE
Mechanism Histamine H1 receptor antagonist
Target Histamine H1 receptor
Route OPHTHALMIC
Formulation DRUG-ELUTING CONTACT LENS

Mechanism of action

Histamine H1 receptor antagonist

Primary target: Histamine H1 receptor

Approval history

Authority Status Date
FDA approved

Related & competitor drugs

  1. azelastine hydrochloride Histamine H1 receptor antagonist
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  4. cetirizine hydrochloride Histamine H1 receptor antagonist
  5. chlorpheniramine maleate Histamine H1 receptor antagonist
  6. clemastine fumarate Histamine H1 receptor antagonist
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Frequently asked questions

What is ketotifen fumarate?

ketotifen fumarate (KETOTIFEN FUMARATE) is a histamine h1 receptor antagonist. Associated with Essential Pharma Limited. Route of administration: ophthalmic. Current US regulatory status: approved.

What is the brand name for ketotifen fumarate?

KETOTIFEN FUMARATE is a marketed brand name for ketotifen fumarate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ketotifen fumarate?

ketotifen fumarate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.