Navigation Links
FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents
Date:6/30/2008

WOODCLIFF LAKE, N.J., June 30 /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 approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above.

Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients. In this study, ACIPHEX was well tolerated in adolescent subjects, with a safety profile similar to that of adults. The adverse events reported without regard to relationship to ACIPHEX that occurred in greater than or equal to 2 percent of 111 patients were headache (9.9 percent), diarrhea (4.5 percent), nausea (4.5 percent), vomiting (3.6 percent) and abdominal pain (3.6 percent). Efficacy results demonstrated that once-daily treatment with ACIPHEX 20 mg for eight weeks reduced the severity and frequency of GERD symptoms compared to symptoms prior to treatment.

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. ACIPHEX 20 mg tablet once daily is approved for use in adults:

-- for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) Gastroesophageal Reflux Disease (GERD).

-- to maintain healing of damage (erosions) and relief of heartburn symptoms with GERD. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).

-- for the treatment of day-time and night-time heartburn and other symptoms that happen with GERD.

ACIPHEX 20 mg once daily is now also indicated for adolescents ages 12 and above for the short-term treatment (up to 8 weeks) for heartburn and ot
'/>"/>

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

1

GOOD

Page: 1 2 3

Related biology technology :

1. FDA Approves CONCERTA(R) (methylphenidate HCI) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults
2. FDA Approves Quark IND for DGFi, an siRNA Therapeutic Based on Silence Therapeutics Unique Proprietary Chemistry
3. Big Win for Biodiesel: ASTM Approves New Biodiesel Blend Specifications
4. FDA Approves GlaxoSmithKlines AVODART(R) in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate
5. Arpida Annual General Meeting of Shareholders Approves All Board Proposals
6. FDA Approves MIXJECT(TM), a Convenient, Easy-to-Use Drug Delivery System For Watson Pharmaceuticals TRELSTAR(R) DEPOT and TRELSTAR(R) LA
7. FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
8. Maryland Approves Medicaid Reimbursement for ActiPatch(R)
9. Healthcare Coalition Approves Tools to Improve Patient Safety During Transitions of Care
10. Medicare Approves in Home Sleep Apnea Testing
11. 3SBio Inc. Approves Share Repurchase Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2010)... from NASA’s Kennedy Space Center this morning, carrying on board ... created to use microgravity to develop the foundation of new ... ... 2010 -- Space Shuttle Endeavor lifted off from NASA’s Kennedy ... payload for Astrogenetix, a commercial biotech company created to use ...
(Date:2/8/2010)... , Feb. 8 Biocell ... with maternal-fetal-medicine doctors by attending the Society for ... has been working with perinatologists and Ob/Gyn doctors ... , CEO of Biocell Center Corporation. "We understand ... mothers and families and we are hoping to ...
(Date:2/8/2010)... MBS Value Partners, a strategic communications ... for domestic and international clients, announced today that ... have joined as Managing Directors. ,, ... corporate experience that will serve our clients well,” ... “Lisa’s and Matt’s significant experience in clean technology ...
(Date:2/8/2010)... Neurocrine Biosciences, Inc. (Nasdaq: NBIX ... Rastetter Ph.D. to its Board of Directors effective immediately. ... of Receptos, Inc., and former Executive Chairman of Biogen ... Bill Rastetter to our Board of Directors," ... the Board of Neurocrine Biosciences.  "The company is very ...
Breaking Biology Technology:Astrogenetix Continues MRSA Vaccine Development Onboard Endeavor 2Astrogenetix Continues MRSA Vaccine Development Onboard Endeavor 3Biocell Center Furthers Its Commitment to Maternal-Fetal Medicine 2MBS Value Partners Hires Two New Senior Staff Members 2Neurocrine Biosciences Announces the Appointment of William H. Rastetter to Its Board of Directors 2
... research collaboration to improve insect control in corn and soybeans. ... ... (Vocus) January 15, 2009 -– DuPont and Athenix today announced they ... corn and soybeans. Under the agreement, DuPont business Pioneer ...
... Regado Biosciences, Inc., announced today the appointment of ... of Senior Vice President, Clinical and Medical Affairs ... will report to David J. Mazzo, Ph.D., the ... "Steven has led clinical programs for more than ...
... Large-scale cellulosic ethanol facility in Florida to serve ... Fuel" grant provides State support to project -CAMBRIDGE, ... VRNM ), a pioneer in the development ... today announced plans to build its first commercial-scale ...
Other Biology Technology:DuPont and Athenix Collaborate to Advance Insect Control in Corn, Soybeans 2DuPont and Athenix Collaborate to Advance Insect Control in Corn, Soybeans 3Dr. Steven L. Zelenkofske Joins Regado Biosciences as Senior Vice President, Clinical and Medical Affairs and Chief Medical Officer 2Dr. Steven L. Zelenkofske Joins Regado Biosciences as Senior Vice President, Clinical and Medical Affairs and Chief Medical Officer 3Verenium Announces First Commercial Cellulosic Ethanol Project 2Verenium Announces First Commercial Cellulosic Ethanol Project 3Verenium Announces First Commercial Cellulosic Ethanol Project 4Verenium Announces First Commercial Cellulosic Ethanol Project 5Verenium Announces First Commercial Cellulosic Ethanol Project 6
(Date:2/8/2010)... wealth of data about how cells respond to stimuli, ... a daunting challenge. In a study published online ... have developed a novel method of interpreting data from ... offering a glimpse into the future of high-throughput cell ... through a microscope at cells as they change appearance ...
(Date:2/8/2010)... NEW YORK , Feb. 8 ... in Massachusetts resulting in the loss ... care reform with the promise of universal coverage for ... to Standard & Poor,s Equity Research.  President Obama recently ... been to passing what has been for many a ...
(Date:2/8/2010)... of the female reproductive tract, representing 6% of all ... biomarker to indicate early presence of disease. "It is ... ages" comments paper author Dr. Diego Castrillon. The ... inner lining of the uterus, which is called the ... of abnormal bleeding. , The normal endometrium is ...
Breaking Biology News(10 mins):Method of the future uses single-cell imaging to identify gene interactions 2S&P Equity Research; Health Care Reform After The Buzzsaw - Where Are We Now? 2S&P Equity Research; Health Care Reform After The Buzzsaw - Where Are We Now? 3S&P Equity Research; Health Care Reform After The Buzzsaw - Where Are We Now? 4S&P Equity Research; Health Care Reform After The Buzzsaw - Where Are We Now? 5S&P Equity Research; Health Care Reform After The Buzzsaw - Where Are We Now? 6S&P Equity Research; Health Care Reform After The Buzzsaw - Where Are We Now? 7S&P Equity Research; Health Care Reform After The Buzzsaw - Where Are We Now? 8S&P Equity Research; Health Care Reform After The Buzzsaw - Where Are We Now? 9A potent suppressor of endometrial cancer is revealed 2Virginia Hospital Center Seeks to Reduce Operating Costs and Improve Supply Chain with Broadlane 49001 1Virginia Hospital Center Seeks to Reduce Operating Costs and Improve Supply Chain with Broadlane 49001 2Virginia Hospital Center Seeks to Reduce Operating Costs and Improve Supply Chain with Broadlane 49001 3Virginia Hospital Center Seeks to Reduce Operating Costs and Improve Supply Chain with Broadlane 49001 4Virginia Hospital Center Seeks to Reduce Operating Costs and Improve Supply Chain with Broadlane 49001 5Virginia Hospital Center Seeks to Reduce Operating Costs and Improve Supply Chain with Broadlane 49001 6Broadlane Selects Silver Creek Systems To Accelerate Core Business Analysis And New Client Services 48999 1Broadlane Selects Silver Creek Systems To Accelerate Core Business Analysis And New Client Services 48999 2Broadlane Selects Silver Creek Systems To Accelerate Core Business Analysis And New Client Services 48999 3Dr Julian Whitaker Featured on Searchbloodsugar com 48995 1Dr Julian Whitaker Featured on Searchbloodsugar com 48995 2Dr Julian Whitaker Featured on Searchbloodsugar com 48995 3
... who loves to chew people out, or if you work with ... you were, chances are your nestmates might bite you to communicate ... the colony, according to research by a University of Washington animal ... of the social wasp Polybia occidentalis recruit new foragers to gather ...
... Minnesota researcher has found a universal rule that regulates the ... may also offer a key to calculating their carbon dioxide ... to construct valid models of global carbon dioxide cycling. ... animals through the process of respiration; Peter Reich, a professor ...
... the small, big-eyed primates native to the island of ... the open access journal BMC Evolutionary Biology, a team ... of lemurs based on differences in a specific gene ... areas. They had not been identified from morphological differences ...
Other Biology News:Taking a bite out of a fellow worker helps wasps recruit new foragers 2Of mice, men, trees and the global carbon cycle 2Of mice, men, trees and the global carbon cycle 3
Mouse anti-Insulin-Like-3 Class: Antibody Product Group: Adipokine and Obesity related...
... - Red, 20X Immunogen ... at 20X concentration for use in ... Quality Assurance ... fluorescence polarization assays. ...
Anti-Kusabira Orange Monoclonal Antibody Description: 100 g Research Focus: tag Storage: -20C Shipping Temperature: 4C...
Anti-Kusabira Orange Monoclonal Antibody Description: 100 g Research Focus: tag Storage: -20C Shipping Temperature: 4C...
Biology Products: