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news.Eisai's Aciphex (rabreprazole sodium) has met the FDA's Written Request requirements for pediatric exclusivity in US.
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Having met FDA’s requirement, the company has now gained an additional 6 months US market exclusivity for Aciphex, which will expire on 8 November 2013.
The granting of pediatric exclusivity does not approve Aciphex to be used in pediatric patients, according to the company.
The company’s New Drug Application for Aciphex delayed-release sprinkle capsules 5mg and 10mg is also awaiting FDA approval.
Aciphex delayed-release sprinkle capsules are indicated for curing Gastroesophageal Reflux Disease (GERD), maintenance of healing of GERD and improvement of GERD symptoms in children 1 to 11 years of age.