Friday, December 7, 2012

Eisai gets priority review from USFDA for its pediatric NDA for Aciphex

Eisai Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's New Drug Application (NDA) for a new sprinkle capsule formulation (5mg and 10mg) of the proton-pump inhibitor AcipHex (generic name: rabeprazole sodium, product name in Japan: Pariet) for the healing and maintenance of healing of gastroesophageal reflux disease (GERD) and symptom improvement of GERD in children ages 1 to 11. Furthermore, the FDA has indicated that this NDA will receive a priority review, which provides for a six-month review period, with a Prescription Drugs User Fee Act (PDUFA) action date (proposed review deadline) of March 27, 2013.

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