Trial Profile

A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 10 Apr 2023

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At a glance

Drugs Bepotastine (Primary) ; Ketotifen
Indications Pruritus
Focus Registrational; Therapeutic Use
Sponsors Mitsubishi Tanabe Pharma Corporation

Most Recent Events

26 May 2015 Mitsubishi Tanabe received approval for bepotastine [Talion and Talion OD tablets] for additional pediatric allergic diseases (for children at least seven years of age) in Japan. This approval was based on efficacy and safety results from trials conducted in pediatric patients in Japan.
13 May 2014 New trial record

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