FDA Accepts AcipHex® (rabeprazole sodium) Pediatric NDA for Priority Review
WOODCLIFF LAKE, N.J., Nov. 30, 2012 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review Eisai's New Drug Application (NDA) for AcipHex® 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 to 11 years of age.
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 currently approved AcipHex 20mg:
In adults (>18 years of age), one ACIPHEX 20mg tablet daily is used for the treatment of daytime and nighttime heartburn and other symptoms associated with acid reflux disease. ACIPHEX is also used for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) acid reflux disease (gastroesophageal reflux disease) and to maintain healing of damage (erosion) and relief of heartburn symptoms that happen with acid reflux disease. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).
In adolescents (>12 years of age), one ACIPHEX 20mg tablet daily is used for the treatment of daytime and nighttime heartburn and other symptoms associated with acid reflux disease.
Important Safety Information about AcipHex 20mg
Symptom relief does not rule out other serious stomach conditions.
Serious allergic reactions may occur. Tell your doctor if you have a rash, face swelling, throat tightness, or difficulty breathing.
Proton Pump Inhibitor (PPI) medicines may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. If you have watery stool, stomach pain, and fever that does not go away, call your doctor immediately.
People who are taking multiple daily doses of PPI medicines for a long period of time may have an increased risk of fractures of the hip, wrist, or spine.
Low magnesium can happen in some people who take a PPI medicine for at least 3 months. Tell your doctor right away if you experience any of these symptoms: seizures, dizziness, abnormal or fast heartbeat, jitteriness, jerking movements or shaking (tremors), muscle weakness, spasms of the hands and feet, cramps or muscle aches, or spasm of the voice box.
In adolescents, the most common side effects with ACIPHEX include headache, diarrhea, nausea, vomiting, and abdominal pain.
In adults, the most common side effects with ACIPHEX include pain, sore throat, gas, infection, and constipation.
Before taking ACIPHEX, tell your doctor if you are taking any of these medicines: atazanavir, digoxin, iron salts, ketoconazole, warfarin, or methotrexate.
For more information about ACIPHEX, see full Prescribing Information or go to www.Aciphex.com.
About Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.
Marcia J. Diljak
SOURCE Eisai Inc.