- For Print
- February 1, 2008
Ʊ., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) submitted an application in Japan for a new indication of non-erosive gastro-esophageal reflux disease for Pariet®, a proton pump inhibitor, on March 27, 2006. As a result of consultation with the Pharmaceuticals and Medical Devices Agency, Ʊ has made a decision to conduct additional study which will support the submitted data from the original application. Therefore, Ʊ will withdraw the application at this time, and aims to resubmit it in FY2008.
Pariet® was launched first in Japan in 1997. Following that, the product began to be marketed in the Europe in 1998 and in the U.S. (by the brand name AcipHex®) in 1999. Currently, Pariet® is approved in 97 countries around the world.
According to the clinical studies, Pariet® has shown a rapid onset of action, a stable inhibitory effect on acid secretion with the approved indication in Japan including stomach ulcers, duodenal ulcers, gastro-esophageal reflux disease, and as a supplemental treatment for Helicobacter pylori eradication in gastric/duodenal ulcers.