Published on March 3, 2008 at 2:33 PM
Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., has announced that the Food and Drug Administration (FDA) has accepted an ACIPHEX supplemental New Drug Application (sNDA) for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in patients ages 12-16.
Further, FDA has indicated that the sNDA will receive priority review in accordance with the Best Pharmaceuticals for Children Act, which provides for a 180-day review period.
ACIPHEX was discovered and developed by Eisai and is copromoted in the United States with PriCara(R), a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
About ACIPHEX(R) (rabeprazole sodium)
ACIPHEX(R) is a prescription medication. One ACIPHEX 20 mg tablet daily is used in adults for the treatment of persistent, frequent (2 or more days a week) heartburn and other symptoms associated with acid reflux disease.
ACIPHEX is also used in adults for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) acid reflux disease (gastroesophageal reflux disease).
Important Safety Information
ACIPHEX has a well-established safety profile. The most common side effect possibly related to ACIPHEX is headache. Symptom relief does not rule out other serious stomach conditions. Patients on warfarin (such as Coumadin(R)) may need to be monitored more closely by their doctor. To learn more, talk to your doctor and see the full product information at www.aciphex.com.
http://www.eisai.com/