FDA accepts application for GERD drug in children

Eisai says agency to decide whether to approve AcipHex for children by March 2013

WOODCLIFF LAKE, N.J. — The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

Eisai said the FDA accepted its application for AcipHex delayed-release sprinkle capsules in the 5-mg and 10-mg strengths for healing of gastroesophageal reflux disease, and maintenance of healing of GERD and improvement of symptoms in children ages 1 year to 11 years.

The FDA expects to have the application reviewed by March 27, 2013. The drug is currently approved in the 20-mg strength for adolescents and adults.


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