Eisai Granted Additional Six Month U.S. Marketing Exclusivity For Aciphex (Rabeprazole Sodium)
WOODCLIFF LAKE, N.J., Dec. 11, 2012 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) determined that Eisai has met the FDA's Written Request requirements for pediatric exclusivity for ACIPHEX® (rabreprazole sodium). As a result, Eisai has now gained an additional 6 months of United States market exclusivity for ACIPHEX, which will expire on November 8, 2013.
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The granting of pediatric exclusivity does not mean that ACIPHEX is approved for use in pediatric patients. Eisai has a New Drug Application (NDA) pending before the FDA 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. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of March 27, 2013.
Indications for currently approved ACIPHEX 20mg:
In adults (greater than or equal to 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 (greater than or equal to 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 of 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 (rabeprazole sodium), 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.
Web Site: http://www.eisai.com
Posted: December 2012
