isai Receives Complete Response Letter from FDA for Rabeprazole Sodium Extended-Release Capsules, 50 mg for GERD
February 02, 2011 01:33 AM Eastern Time
WOODCLIFF LAKE, N.J.--(EON: Enhanced Online News)--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-erosive GERD.
The FDA issues a Complete Response Letter to indicate that the review cycle of an application is complete ....
.....and the application is not ready for approval. Eisai will work with the FDA to address the requirements of the Complete Response Letter for the approval of rabeprazole sodium extended-release capsules, 50 mg.
