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Article: FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents.
- Article from:
- PR Newswire
- Article date:
- June 30, 2008
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WOODCLIFF LAKE, N.J., June 30 /PRNewswire/ -- Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced today that the Food and Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above.
Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients. In this study, ACIPHEX was well tolerated in adolescent subjects, with a safety profile similar to that of adults. The adverse events reported without regard to ...