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Eisai receives approval for ACIPHEX Sprinkle.

M2 PHARMA-March 29, 2013-Eisai receives approval for ACIPHEX Sprinkle(C)2013 M2 COMMUNICATIONS

Eisai (TYO: 4523), a Japan-based pharmaceutical company, has received approval from the US FDA for ACIPHEX Sprinkle as a 12-week gastroesophageal reflux disease therapy for use in children between one to eleven years of age.

It was reported yesterday that the company has received the approval based on positive data from a multi-centre, double-blind trial conducted in 127 paediatric patients between one to 11 years of age with gastroesophageal reflux disease.

The parallel-group study included a treatment period of 12 weeks and an extension period of two dose levels of rabeprazole for 24 weeks.

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Publication:M2 Pharma
Date:Mar 29, 2013
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