FDA Accepts Aciphex Pediatric NDA for Priority Review
Eisai announced that the FDA has accepted for priority review its New Drug Application (NDA) for Aciphex (rabeprazole sodium) delayed-release sprinkle capsules 5mg and 10mg for the proposed indication of healing of gastroesophageal reflux disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children 1–11 years of age. Rabeprazole is a proton pump inhibitor.
Acceptance of the NDA indicates that the FDA has found the company's submission to be sufficiently complete to review. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of March 27, 2013.
Indications for the currently approved Aciphex 20mg delayed-release enteric-coated tablets include: treatment of daytime and nighttime heartburn and other symptoms associated with acid reflux disease in adults (>18 years of age), short-term (4–8 weeks) treatment in the healing and symptom relief of erosive gastroesophageal reflux disease in adults, maintenance healing of erosion and relief of heartburn symptoms that happen with acid reflux disease in adults, and treatment of daytime and nighttime heartburn and other symptoms associated with acid reflux disease in adolescents (>12 years of age).For more information call (888) 422-4743 or visit www.eisai.com.