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FDA Accepts Pediatric NDA for Proton Pump Inhibitor AcipHex (Rabeprazole)

Priority review set for March 2013 (Nov. 30)

The FDA has accepted for review the New Drug Application (NDA) for a sprinkle capsule formulation (5 mg and 10 mg) of the proton pump inhibitor AcipHex (rabeprazole sodium, Eisai) for healing and maintenance of healing of gastroesophageal reflux disease (GERD) and for symptom improvement of GERD in children aged 1 to 11 years. The agency has indicated that the NDA will receive priority review, with a proposed review deadline of March 27, 2013.

As a proton pump inhibitor, AcipHex suppresses gastric acid secretion while inhibiting enzyme activity during the last phase of stomach acid secretion. The drug was originally launched in the U.S. in 1999 for the healing and maintenance of healing of erosive and ulcerative GERD, for the treatment of symptomatic GERD, for the healing of duodenal ulcers, and for the eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence. The drug is also indicated for adolescent patients aged 12 years and older for the short-term treatment of symptomatic GERD.

Source: Eisai; November 30, 2012.


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