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:7/25/2014)... 25, 2014 Cardinal Health will today name ... winners of its prestigious Independent Pharmacy Best Practices Competition, ... of the nation,s largest gatherings of independent pharmacists. ... pharmacies from Ohio , ... – were selected for implementing exceptionally creative methods that ...
(Date:7/25/2014)... July 25, 2014 According to ... "Global and China Insulin Market (Rapid-Acting, Short-Acting, Intermediate-Acting, Long-Acting, ... Share, Growth, Trends and Forecast (Value and Volume), 2013 ... USD 19.99 billion in 2012 and is expected to ... 2019 to reach USD 32.24 billion in 2019. ...
(Date:7/25/2014)... Laboratories, Inc. (NASDAQ: IDXX ) today reported ... 11% versus the prior year period to $390 million. ... of 2014 versus the prior year period was 9%, ... . Earnings per diluted share ("EPS") for the quarter ... year period to $1.10."In the second quarter, we continued ...
Breaking Medicine Technology:Cardinal Health Announces Three Best Practice Winners for Leading Change in Community Pharmacy 2Cardinal Health Announces Three Best Practice Winners for Leading Change in Community Pharmacy 3Cardinal Health Announces Three Best Practice Winners for Leading Change in Community Pharmacy 4Cardinal Health Announces Three Best Practice Winners for Leading Change in Community Pharmacy 5Cardinal Health Announces Three Best Practice Winners for Leading Change in Community Pharmacy 6Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 2Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 3Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 4IDEXX Laboratories Announces Second Quarter Results 2IDEXX Laboratories Announces Second Quarter Results 3IDEXX Laboratories Announces Second Quarter Results 4IDEXX Laboratories Announces Second Quarter Results 5IDEXX Laboratories Announces Second Quarter Results 6IDEXX Laboratories Announces Second Quarter Results 7IDEXX Laboratories Announces Second Quarter Results 8IDEXX Laboratories Announces Second Quarter Results 9IDEXX Laboratories Announces Second Quarter Results 10IDEXX Laboratories Announces Second Quarter Results 11IDEXX Laboratories Announces Second Quarter Results 12IDEXX Laboratories Announces Second Quarter Results 13IDEXX Laboratories Announces Second Quarter Results 14IDEXX Laboratories Announces Second Quarter Results 15IDEXX Laboratories Announces Second Quarter Results 16IDEXX Laboratories Announces Second Quarter Results 17IDEXX Laboratories Announces Second Quarter Results 18IDEXX Laboratories Announces Second Quarter Results 19IDEXX Laboratories Announces Second Quarter Results 20IDEXX Laboratories Announces Second Quarter Results 21IDEXX Laboratories Announces Second Quarter Results 22IDEXX Laboratories Announces Second Quarter Results 23IDEXX Laboratories Announces Second Quarter Results 24IDEXX Laboratories Announces Second Quarter Results 25IDEXX Laboratories Announces Second Quarter Results 26IDEXX Laboratories Announces Second Quarter Results 27IDEXX Laboratories Announces Second Quarter Results 28
... Study Reveals that Thoracic Endoluminal Grafting is a Feasible Alternative ... TO Open Surgical Repair, J Vasc Surg. 2007 Sep; 46(3):413-20. ... JA, Olsen DM, Shtutman A, Lucas LA, Wheatley G, Alpern J, Ramaiah V, Diethrich ... ...
... The National Institute of,Standards and Technology (NIST) ... in the Commerce Department,s Advanced Technology Program,(ATP), a ... awarded to the early-phase Michigan biotechnology company developing,drug ... and,other bone disorders. Velcura scientists have discovered ...
Cached Medicine Technology:Video: The Arizona Heart Institute Announces the Largest Worldwide Experience with Endoluminal Grafting to Treat Thoracic Aortic Aneurysms and Related Pathologies 2Video: The Arizona Heart Institute Announces the Largest Worldwide Experience with Endoluminal Grafting to Treat Thoracic Aortic Aneurysms and Related Pathologies 3Video: The Arizona Heart Institute Announces the Largest Worldwide Experience with Endoluminal Grafting to Treat Thoracic Aortic Aneurysms and Related Pathologies 4Video: The Arizona Heart Institute Announces the Largest Worldwide Experience with Endoluminal Grafting to Treat Thoracic Aortic Aneurysms and Related Pathologies 5Video: The Arizona Heart Institute Announces the Largest Worldwide Experience with Endoluminal Grafting to Treat Thoracic Aortic Aneurysms and Related Pathologies 6NIST Awards $2 Million to Velcura Therapeutics, Inc. for Innovative Technology R&D - Dual-Action Therapies for Bone Disease 2
(Date:7/25/2014)... 2014 On July 22, 2014, ... client and the nation’s number one provider of ... announced their partnership with TransAct Merchant Solutions’ National ... ISO/MSP of Chase Paymentech Solutions, LLC, which provides ... Companies that are members of TransAct’s National Association ...
(Date:7/25/2014)... 25, 2014 This is a ... of the Galactooligosaccharides (GOS) industry in Global ... of the industry, including definitions, applications and industry ... market analysis are provided with a focus on ... market. A comparison between the international and Chinese ...
(Date:7/25/2014)... Philadelphia, PA (PRWEB) July 25, 2014 ... that Valerie D. Weber, MD, MS, FACP, has been appointed ... , Weber will join Drexel from The Commonwealth Medical College, ... Sciences, associate dean for clinical affairs, and professor of medicine. ... of The Commonwealth Medical College, Weber had a major role ...
(Date:7/25/2014)... workers, especially men, may be at higher risk for type ... new study suggests. Also at special risk are shift ... moving around at various times of the day. The ... Alan Manevitz, a clinical psychiatrist at Lenox Hill Hospital in ... shifts disrupts many key body chemicals, creating a ripple effect ...
(Date:7/25/2014)... --, Treatment for lymphoma may lower men,s fertility, new ... which are cancers of the body,s white blood cells, ... reproductive years. For men, treatment for these cancers can ... their fertility within two years of treatment, the researchers ... of this significant side effect before treatment begins. ...
Breaking Medicine News(10 mins):Health News:Nuanced Media Client, CEDR HR Solutions, Partners with TransAct to Serve Medical, Dental, and Eye Care Professionals 2Health News:GOS Market (Galacto-oligosaccharides) Development in Global & China Regions Now Available at DeepResearchReports.com 2Health News:GOS Market (Galacto-oligosaccharides) Development in Global & China Regions Now Available at DeepResearchReports.com 3Health News:Valerie D. Weber, MD, Appointed Vice Dean for Education at Drexel University College of Medicine 2Health News:Valerie D. Weber, MD, Appointed Vice Dean for Education at Drexel University College of Medicine 3Health News:Study Links Shift Work to Risk for Type 2 Diabetes 2Health News:Study Links Shift Work to Risk for Type 2 Diabetes 3Health News:Lymphoma Treatment May Harm, Halt Men's Sperm Production 2
... ALEXANDRIA, Va., Feb. 12 An article published in ... the American Medical Association helps physicians to better ... determine which end-of-life care options may be best for ... life have increased in recent years. With more ...
... Calif., Feb. 12 Fisher Vista, LLC, a marketing,and ... human resource,industries today announced that Kevin Grossman, who has ... president of its HRmarketer.com division. , ... overall responsibility of,HRmarketer.com and the HRmarketer Services Group. ...
... BASKING RIDGE, N.J., Feb. 12 Regado Biosciences, ... President and Chief Executive Officer, will be presenting ... Philadelphia, PA on Friday, February 20, 2009, at ... a review of the Company,s lead development product, ...
... of prescribing system to avoid ,alert fatigue, , , ... override electronic medication safety alerts and rely instead ... patients, which suggests that physicians find the alerts ... , Researchers looked at the electronic prescriptions ...
... 2009 Oral-B(R) Stages, the dental,professional,s #1 recommended ... a campaign in recognition of National Children,s Dental ... about the state of children,s,oral health in America, ... parents and,healthcare providers alike. In fact, tooth ...
... 12 Kovarus, Inc., a premier,technology consulting firm, and ... today jointly announced the launch of a new bike ... awareness of a good cause,the American Brain Tumor Association ... http://www.newscom.com/cgi-bin/prnh/20080708/AQTU138LOGO ) , The Studio ...
Cached Medicine News:Health News:JAMA Article Provides Guidance to Physicians on End-of-Life Care 2Health News:Kevin Grossman Named President of HRmarketer.com 2Health News:Docs Override Most Electronic Drug Warnings 2Health News:Oral-B Addresses Children's Oral Health Needs at All Stages of Development During National Children's Dental Health Month 2Health News:Oral-B Addresses Children's Oral Health Needs at All Stages of Development During National Children's Dental Health Month 3Health News:Oral-B Addresses Children's Oral Health Needs at All Stages of Development During National Children's Dental Health Month 4Health News:Oral-B Addresses Children's Oral Health Needs at All Stages of Development During National Children's Dental Health Month 5Health News:Oral-B Addresses Children's Oral Health Needs at All Stages of Development During National Children's Dental Health Month 6Health News:Biking for Fun, Sport, and Brain Tumor Awareness 2Health News:Biking for Fun, Sport, and Brain Tumor Awareness 3
The Vitek 2 is a fully automated bacteriology system that performs bacterial identification and susceptibility testing analysis using a standard inoculum. It detects resistance and helps combat bacte...
IDS Rapid Yeast Plus, a microbial identification system....
IDS Rapid NH, a microbial identification system....
The Cogent Microbial Luminescence System (MLS) is a superior Rapid microbial detection system for UHT product screening combining proven technology of ATP-bioluminescence with unsurpassed hardware in...
Medicine Products: