• Eisai Inc., of Woodcliff Lake, N.J., said the FDA determined that the company has met the agency's written request requirements for pediatric exclusivity for Aciphex (rabreprazole sodium). As a result, Eisai now has gained an additional six months of U.S. market exclusivity for Aciphex, which will expire on Nov. 8, 2013. The granting of pediatric exclusivity does not mean that Aciphex is approved for use in pediatric patients. Eisai has a pending new drug application for Aciphex delayed-release sprinkle capsules 5 mg and 10 mg for the proposed indication of gastroesophageal reflux disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children, ages 1 to 11. The FDA assigned a PDUFA date of March 27, 2013.