Eisai receives complete response letter from US FDA for investigational proton pump inhibitor Aciphex Extended-Release Capsules 50mg.

On 2 Feb 2011, Eisai Co Ltd announced that its US subsidiary Eisai Inc received a Complete Response Letter from the US Food and Drug Administration (FDA) on 1 Feb 2011 (local time) regarding the New Drug Application (NDA) of AcipHex (Brand name in Japan: Pariet; generic name: rabeprazole sodium) extended-release capsules, 50mg, 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 the review cycle of an …