FDA Accepts AcipHex® (rabeprazole sodium) Pediatric NDA for Priority Review

 FDA Accepts AcipHex® (rabeprazole sodium) Pediatric NDA for Priority Review

PR Newswire

WOODCLIFF LAKE, N.J., Nov. 30, 2012

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.

(Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO)

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

  oSymptom relief does not rule out other serious stomach conditions.
  oSerious allergic reactions may occur. Tell your doctor if you have a rash,
    face swelling, throat tightness, or difficulty breathing.
  oProton 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.
  oPeople 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.
  oLow 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.
  oIn adolescents, the most common side effects with ACIPHEX include
    headache, diarrhea, nausea, vomiting, and abdominal pain.
  oIn adults, the most common side effects with ACIPHEX include pain, sore
    throat, gas, infection, and constipation.
  oBefore 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. 


CONTACT:
Media Inquiries Investor Inquiries
Marcia J. Diljak   Alex Scott
Eisai Inc.         Eisai Inc.
201-746-2236       201-746-2177

SOURCE Eisai Inc.

Website: http://www.eisai.com
 
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