Eisai Inc. (Headquarters: Woodcliff Lake, NJ; Chairman and CEO: Hajime Shimizu), a U.S. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo; President and CEO: Haruo Naito) today announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai's New Drug Application (NDA) for rabeprazole sodium extended-release 50 mg for the healing and maintenance of healing of erosive gastroesophageal reflux disease (GERD), and for the treatment of symptomatic GERD. The application is based on results from six recently completed Phase III studies involving more than 4,000 patients.
Acceptance of the NDA indicates that the FDA has found the company's submission to be sufficiently complete to review. The NDA was submitted to FDA on March 31, 2010.
Rabeprazole sodium extended-release 50 mg capsules is a new formulation which combines two different kinds of drug releasing mechanisms in one capsule. Rabeprazole sodium delayed release tablets are currently marketed by Eisai Inc. as ACIPHEX® (rabeprazole sodium). ACIPHEX was discovered and developed by Eisai and is copromoted in the United States with PriCara®, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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