Navigation Links
FDA Grants Priority Review for ACIPHEX(R) (rabeprazole sodium) sNDA for Short-Term Treatment of GERD in Adolescents
Date:2/29/2008

WOODCLIFF LAKE, N.J., Feb. 29 /PRNewswire/ -- Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced today 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 http://www.aciphex.com.

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastroint
'/>"/>

SOURCE Eisai Corporation of North America
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
2. FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial
3. NTMir Announces Research Grants for Epidemiology and Household Water as Source of Infection
4. Ethics Group Asks USAID Inspector General to Investigate Legality of Grants to Soros Groups
5. Chinese SFDA Grants Immtech Fast Track Status
6. US FDA Grants Orphan Drug Status to Immtechs Pafuramidine for Treatment of African Sleeping Sickness
7. Inclusion of Six-Year Overall Survival Data in the Eloxatin(R) (oxaliplatin injection) Prescribing Information Granted FDA Priority Review
8. Advanced Life Sciences Collaborates with U.S. Government to Study Cethromycin as Treatment for Anthrax and Other High-Priority Biodefense Agents
9. Micromet Announces the Publication of BiTE Antibody Review in Drugs of the Future
10. FDA Extends Review of Genasense(R) NDA Appeal in Chronic Lymphocytic Leukemia
11. Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)...  Medical Science Liaisons play a large role in ... medical device industry and key stakeholders, the role of ... as the device industry relies on them to build ... benchmarking firm, Best Practices, LLC, one area where Medical ... by harnessing new technology to enable education. Online conferences ...
(Date:12/22/2014)... , Dec. 22, 2014 Apnea Sciences ... corporate offices in Aliso Viejo , ... due to the tremendous growth and worldwide expansion, a ... of patented SnoreRx, the anti snore cure have exceeded ... said, "We are now in 23 countries and ...
(Date:12/22/2014)... Research and Markets ( http://www.researchandmarkets.com/research/hmlfbq/investment ... "Investment Analysis of the US Medical Device Sector ... http://photos.prnewswire.com/prnh/20130307/600769 This ... sector identifies the key trends and rationale for ... mergers and acquisitions. The study will ...
Breaking Medicine Technology:Role of Medical Science Liaisons Evolving in Medical Device Sector 2Investment Analysis of the US Medical Device Sector 2
... 18, 2011 Bexion Pharmaceuticals was named the Biotech ... program sponsored by the Cincinnati Business Courier, the Cincinnati ... outstanding innovation and the companies and people who have ... for the regional Tri-State (Ohio/Kentucky/Indiana) economic engine. ...
... Md., April 18, 2011 Science, public ... Food and Drug Administration. I nformation in this document ... items are current as of April 18, 2011. ... & Notes does not contain any regulatory or enforcement actions ...
Cached Medicine Technology:Bexion Pharmaceuticals Receives Outstanding Biotech Innovation Award 2FDA News & Notes - Week of April 18, 2011 2
(Date:12/25/2014)... December 25, 2014 BambooFlooringChina.com sells many ... quality bamboo flooring. Today, the company announces big ... many styles and colors. , BambooFlooringChina.com is the world’s ... the promotion is valid until Jan. 20, 2015. , ... and woven with a natural thread. All the bamboo ...
(Date:12/25/2014)... -- The risk of burns from fires and cooking ... be extra cautious, an expert says. "Between Thanksgiving ... in patients coming in with burns," said Dr. Steven ... Burn Center of Stony Brook University Hospital in New ... but if not careful, could quickly turn tragic," Sandoval ...
(Date:12/25/2014)... York (PRWEB) December 25, 2014 Thousands ... to move forward in a number of multidistrict litigations ... West Virginia, Bernstein Liebhard LLP reports. According to an ... scheduled to convene a Joint Status Conference in all ... a.m. Parties have been directed to submit a proposed ...
(Date:12/25/2014)... (PRWEB) December 25, 2014 Parker & ... outstanding customer service and affordable quality regarding heating, cooling ... announces recognition in 2014 by the “Queen of Clean” ... has earned an impressive reputation over the years for ... a wide range of contractor services for both homeowners ...
(Date:12/24/2014)... Recently, iFitDress.com, a famous dress manufacturer and retailer, has ... All these items are brand new; they are made by ... with the new range of high quality prom gowns. A ... designs are made according to the latest trends. For years, ... from the company is handpicked by skilled tailors. , In ...
Breaking Medicine News(10 mins):Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2Health News:Don't Let Burns Mar Your Holidays 2Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 3Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 4Health News:Parker & Sons Announces Recognition In 2014 By The “Queen Of Clean” For Impressive Contractor Services In Arizona 2Health News:Parker & Sons Announces Recognition In 2014 By The “Queen Of Clean” For Impressive Contractor Services In Arizona 3Health News:Many Prom Dresses under 150 from Well-known Dress Manufacturer iFitDress.com 2
... and relaxation exercises can help cut the pain, experts say , ... run away from an injection, so it,s no surprise that children ... it,s time for flu shots this year. , "The good ... to positively impact their child,s experience when getting a needlestick -- ...
... , GAINESVILLE, Fla., Oct. 18 Previously e cigarettes ... product for themselves. However, Teresa Peach, an online sales ... wishing to purchase the product for their loved ones ... they wish to buy the electronic cigarette starter kit ...
... Epileptic seizures are the most dramatic and prominent aspect ... person abruptly stops a long-term or chronic drinking habit. ... into brain cells via voltage-gated calcium channels plays an ... because blocking this flow suppresses these seizures. But do ...
... , FRESNO, Calif., Oct. 17 Nearly 40 local organizations ... the Lowell Neighborhood Resource Center to host the Celebrate ... at Lowell Elementary School from 10:00 a.m. to 2:00 p.m. ... rise to 14.6 percent, the need for local health and ...
... Veterans with disorder more likely to die within a ... 17 (HealthDay News) -- Veterans with post-traumatic stress disorder ... if the surgery is performed years after they have ... Researchers analyzed data on 1,792 male veterans who had ...
... , NASDAQ: CRME ... (NASDAQ: CRME / TSX: COM) ("Cardiome" or the "Company") ... to purchase for cancellation up to US$27.5 million of its common ... October 13, 2009. Cardiome has accepted 6,470,588 of its common shares ...
Cached Medicine News:Health News:Online Sales of E Cigarettes Expected to Rise Over the Holidays 2Health News:Anthem Blue Cross Teams with Lowell Neighborhood Resource Center to Address Health and Wellness Needs in Fresno 2Health News:Post-Traumatic Stress May Raise Death Risks 2Health News:Cardiome Pharma Corp. Announces Final Results of Tender Offer 2Health News:Cardiome Pharma Corp. Announces Final Results of Tender Offer 3Health News:Cardiome Pharma Corp. Announces Final Results of Tender Offer 4
This fixed-volume digital micropipet is used to accurately measure and transfer 50 microliters of solution....
50L...
... Focus from Thermo Labsystems was ... with uncompromising performance. The ... a custom fit for different ... tip cones allow easier and ...
... Eppendorf Reference Series 2000 Pipette is a ... a compact and robust design, and superior ... used to operate the measuring stroke and ... Product features:Eppendorf "pipette/tip" system ensures utmost accuracy ...
Medicine Products: