Rabeprazole sodium extended-release capsules, 50 mg, is an investigational proton pump inhibitor, which is under review for the healing and long-term maintenance of healing and symptom resolution of erosive GERD as well as for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.
A Complete Response Letter is issued by the FDA to indicate that the review cycle of an application is complete and the application is not ready for approval.
According to Eisai, the company will work with the FDA to address the requirements of the Complete Response Letter for the approval of rabeprazole sodium extended-release capsules, 50mg.
Rabeprazole sodium extended-release capsules, 50 mg is being assessed as a new formulation which combines two different drug releasing mechanisms in one capsule for the treatment of patients with GERD.