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

Links shared publicly online about this topic.

536
total visits

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

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

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