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:7/2/2015)... DURHAM, N.C. , July 2, 2015 /PRNewswire/ ... acquisition of assets related to the ion channel biology ... had previously been obtained as part of Pfizer,s 2011 ... of Pfizer,s rights to the "Icagen" name and trademark. ... provide comprehensive services for ion channel and transporter drug ...
(Date:7/2/2015)... de julio de 2015 BGI anunció hoy ... alto rendimiento en Hong Kong ... Pathologists (CAP). La instalación de BGI en Hong ... de próxima generación que recibe la certificación CAP en ... estándar en prácticas de laboratorio clínico. Junto con el ...
(Date:7/2/2015)... 25, 2015 Research and ... "Veterinary / Animal Vaccines Market by Product, Diseases ... to their offering. The global animal vaccines ... from $5,507.3 Million in 2015, at a CAGR of ... fueling market growth are growing prevalence of animal diseases, ...
Breaking Medicine Technology:Icagen Re-launched through XRpro Sciences Acquisition of Pfizer Team and Technology for Ion Channel and Transporter Drug R&D 2Icagen Re-launched through XRpro Sciences Acquisition of Pfizer Team and Technology for Ion Channel and Transporter Drug R&D 3Icagen Re-launched through XRpro Sciences Acquisition of Pfizer Team and Technology for Ion Channel and Transporter Drug R&D 4BGI recibe la acreditación del College of American Pathologists (CAP) 2Veterinary / Animal Vaccines Market 2015 - Global Forecast to 2020 for the $7.19 Billion Industry 2
... await the official no-PSA recommendation from the United States ... well underway. Based on concerns that further testing and even ... primary care physicians plans to advise all healthy men to ... . (Photo:   http://photos.prnewswire.com/prnh/20111011/NY84661 ) ...
... a fall, and you aren,t able to press the button? ... that sends an automatic alert- no need to push a button ... its automatic fall detection. More caregivers and families are responding to ... in the event of an emergency, and are looking for a ...
Cached Medicine Technology:Ignorance is Not Bliss: PSA Test Saves Men's Lives from Prostate Cancer 2Ignorance is Not Bliss: PSA Test Saves Men's Lives from Prostate Cancer 3myHalo Grows as Automatic Fall Detection Becomes a Must-Have 2
(Date:7/2/2015)... ... July 02, 2015 , ... ... for her introduction of the Stop Overdose Stat (S.O.S.) Act of 2015 on ... Reed (D-R.I.), this Act seeks to decrease drug overdose – especially of heroin ...
(Date:7/2/2015)... ... July 02, 2015 , ... Many Fourth of July ... That’s why Amica Insurance is sharing some tips to promote the proper ... 230 people go to the emergency room daily with fireworks-related injuries in the month ...
(Date:7/2/2015)... (PRWEB) , ... July 02, 2015 , ... In 2012, Patrick Achebe realized that the ... was alone. He sat down to write his first poem, and three years later he ... that was special and worth sharing with the world. "I have always believed that the ...
(Date:7/2/2015)... , ... July 02, 2015 , ... As Americans celebrate ... the hot temps, skin cancer is on the rise. July is UV Safety Month, ... raising awareness about the importance of getting skin checks. Experts say most skin cancers ...
(Date:7/2/2015)... PEACHTREE CITY, GA (PRWEB) , ... July 02, 2015 , ... ... introduce their newest innovation in compression socks designed for men. , For style ... compression socks into their daily routine. This is great news for men everywhere because ...
Breaking Medicine News(10 mins):Health News:AAPCC Supports the Stop Overdose Stat Act of 2015 2Health News:AAPCC Supports the Stop Overdose Stat Act of 2015 3Health News:6 Fireworks Safety Tips from Amica Insurance 2Health News:Patrick Achebe Releases Debut Book, Whispering Waves: Poems for Everyday Grace 2Health News:Local Physicians Warn of Holiday Health Hazards 2Health News:Local Physicians Warn of Holiday Health Hazards 3Health News:Local Physicians Warn of Holiday Health Hazards 4Health News:SIGVARIS Kicks Up Its Style for Men with the Launch of MIDTOWN MICROFIBER in a Dark Navy Stripe Pattern 2Health News:SIGVARIS Kicks Up Its Style for Men with the Launch of MIDTOWN MICROFIBER in a Dark Navy Stripe Pattern 3
... addicts to shock therapy as a means to wean them ... Scottish Executive is doing more research into this form of ... Therapy (NET) is executed with the use of self-adhesive electrodes ... into the brain. This is known to bring about a ...
... life hangs between life and death, suffering an extremely rare ... transplant, which will give him a new lease of life. ... will be donating a kidney each. , ,Mrs ... felt so helpless, especially as you're used to doing everything ...
... San Francisco Zoo had knowingly imported parakeets with a contagious ... interaction //. ,While the disease is not infectious ... which causes psittacine beak and feather disease could pose a ... immune system causing abnormal feather growth and beak deformities. No ...
... flu virus found in poultry in Hungary last week was ... //. ,As chief veterinarian Miklos Suth said,‘This afternoon ... the highly pathogenic H5N1 strain of avian influenza which had ... report of the H5N1 virus in poultry in Hungary. ...
... into New Zealand by scientists to clarify with the suspected ... holds the threatening substance for testing it with the suspected ... Wallaceville manager said it has been imported from Australia and ... staffs, wearing safe suits are engaged to deal with the ...
... ,South-east Victoria Sale Hospital's two pediatricians, Jo McCubbin and ... notice with three months notice //. However a ... six months. ,This has led to concerns ... has said that obstetricians would not be able to ...
Cached Medicine News:
Clear Base Stand Magnifiers are ideal for any visual task that requires high magnification....
Thinprofile design eyelid implants....
... The aplanatic lens is made ... lens system consisting of two ... clearly defined, distortion-free image. This ... for patients with macular degeneration ...
Bausch & Lomb round and rectangular magnifiers incorporate precision optics and an ergonomic design for increased clarity and comfort during use...
Medicine Products: