NDAOPHTHALMICSOLUTION/DROPS
Approved
Dec 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
ALAWAY (ketotifen fumarate) by Bausch + Lomb is state, the lens when placed on the cornea, acts as a refracting medium to focus light rays on the retina to correct refractive ametropia for as long as the lens is worn (up to 24 hours while awake). First approved in 2006.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALAWAY is a ketotifen fumarate ophthalmic solution (eye drops) approved in 2006 for allergic conjunctivitis. It is an H1 receptor antagonist and mast cell stabilizer that prevents ocular allergic itch and allows continued contact lens wear during allergen exposure, with efficacy lasting up to 12 hours per dose.
LOE Approaching
Product is approaching loss of exclusivity with modest competitive pressure (30%), signaling potential team consolidation and transition focus to generics support or pipeline transition.
Mechanism of Action
state, the lens when placed on the cornea, acts as a refracting medium to focus light rays on the retina to correct refractive ametropia for as long as the lens is worn (up to 24 hours while awake). Drug Component Ketotifen fumarate, a benzocycloheptathiophene derivative, is a H 1 receptor…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution
Started Apr 2023
512 enrolled
Allergic Conjunctivitis
Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis
Started Nov 2022
229 enrolled
Seasonal Allergic Conjunctivitis
Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis
Started Oct 2022
188 enrolled
Allergic Conjunctivitis
A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
Started Apr 2018
65 enrolled
Allergic Conjunctivitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.