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WOODCLIFF LAKE, N.J. — The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said Tuesday.
Eisai said the FDA had granted six more months of exclusivity for the use of Aciphex (rabreprazole sodium) in children, meaning it will lose market exclusivity on Nov. 8, 2013.
Still, the decision does not mean the drug is approved for use in children, Eisai said. The drug maker has an approval application pending before the FDA for Aciphex delayed-release sprinkle capsules in the 5-mg and 10-mg strength for GERD in children aged 1 to 11, and the FDA expects to complete its review by Nov. 27, 2013.