FDA accepts Eisai's NDA for rabeprazole sodium extended-release 50 mg

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FDA accepts Eisai's NDA for rabeprazole sodium extended-release 50 mg

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 has accepted Eisai's New Drug Application for rabeprazole sodium extended-release 50 mg for the healing and maintenance of healing of erosive gastroesophageal reflux disease, and for the treatment of symptomatic GERD.

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Tags: GERD Medication, Zollinger-Ellison Syndrome Medication, Heartburn Medication, H pylori Infection Medication, Erosive Esophagitis Medication, FDA, Eisai, Oncology

Most Recently Shared on June 3, 2010 at 5:13 am By:

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Oncology News: FDA accepts Eisai's NDA for rabeprazole sodium extended-release 50 mg: Eisai Inc. (Headquarters: Wo... http://bit.ly/ak6CdD

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FDA issues Complete Response Letter for approval of Eisai's rabeprazole sodium extended-release capsules

news-medical.net — “Eisai announced today that the company received a Complete Response Letter from the United States Food and Drug Administration (FDA) regarding the New Drug Application (NDA) of rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive gastroesophageal reflux disease (GERD), and for the treatment of daytime and nighttime heartburn and other symptoms of non-” View full resource at news-medical.net