Navigation Links
U.S. Food and Drug Administration Advisory Committee Recommends Approval of Tolvaptan, an Investigational Treatment for Hyponatremia
Date:6/25/2008

PRINCETON, N.J., Jun. 25 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) Advisory Committee on Cardiovascular and Renal Drugs voted to recommend the approval of tolvaptan, Otsuka Pharmaceutical Development & Commercialization, Inc.'s (OPDC) investigational treatment for patients with hyponatremia.

"Otsuka is pleased that the FDA Advisory Committee supports the potential approval of tolvaptan, an investigational selective V2-vasopressin receptor antagonist," said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer of OPDC. "We believe tolvaptan, if approved by the FDA, has the potential to be an important treatment option for people with hyponatremia."

Hyponatremia, characterized by low concentrations of sodium in the blood, is a known predictor of mortality in patients with serious underlying illnesses.(i) Sodium is an important electrolyte that plays a role in blood pressure maintenance, muscle movement, and fluid regulation in and around cells.(ii) Approximately 3.2 million to 6.1 million people in the U.S. suffer from hyponatremia annually.(iii)

Tolvaptan is an investigational selective antagonist of the vasopressin V2 receptor, which is located predominantly in the kidney and plays a role in the regulation of fluid retention in the body. Vasopressin V2 antagonists work by selectively blocking the V2 receptor. This mechanism of action hinders water reabsorption and results in increased free water excretion (aquaresis), which is characterized by increased urine volume with no increase in urinary electrolyte excretion.

OPDC was established in 2007 by Otsuka America, Inc. (OAI). OPDC is wholly owned by OAI, which is the holding company for Otsuka Pharmaceutical Co., Ltd. (OPC) interests in the U.S. OAI is wholly owned by OPC.

About Otsuka Pharmaceutical Development & Commercialization, Inc.

Otsuka Pharmaceutical Development & Commercialization (OPDC) is involved in conductin
'/>"/>

SOURCE Otsuka Pharmaceutical Development & Commercialization,Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Baxter and Halozyme Announce Collaboration for Development of Subcutaneous GAMMAGARD LIQUID(TM) Administration Using Enhanze(TM) Technology
2. Bioscrypts V-Station MIFARE Placed on Transportation Security Administrations Qualified Products List
3. Australian Therapeutics Goods Administration Approval for ActiPatch Achieved
4. FDA Approves Administration of LEXIVA(R) with Lower Dose of Boosting Medication Ritonavir
5. Korean Food and Drug Administration Approval for ActiPatch Achieved
6. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)
7. New Drug Application for Tolvaptan, Otsukas Investigational Novel Oral Treatment for Worsening Heart Failure and Hyponatremia, Accepted by the U.S. Food and Drug Administration
8. Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration
9. Wyeth Consumer Healthcare Supports U.S. Food and Drug Administration Decision for Over-the-Counter Cough and Cold Medications in Children under Two Years of Age
10. Carrington Subsidiary DelSite Starts Making Test Batches of First Bird Flu Vaccine Offering Needle-free Self-Administration
11. PPD Confirms Takedas NDA Filing of Alogliptin with U.S. Food and Drug Administration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/20/2014)... -- GenVec, Inc. (NASDAQ: GNVC ) today announced the ... board of directors effective on October 24, 2014.   Dr. Horovitz ... its chairman from June 2006 to November 2013.  During his ... and Audit Committees of the board.  "We ... service to GenVec, and its stockholders," said Wayne T. ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 ... Partners LLC, announced today that Ellen Teplitzky, an ... support for the pharmaceutical industry, has joined the ... of its legal services practice. NDA Partners ... expert witness and testimony, to top law firms ...
(Date:10/19/2014)... 2014 OCTOBER 20-22, 2014: ... ABIM will take place at the ... ABIM 2014 is now available at ... companies and organizations from all over the ... on the latest products and developments on ...
(Date:10/19/2014)... October 19, 2014 The Asian Automatic ... Asian with analysis and forecast of revenue. The Automatic ... to around $463.9 million by 2018, at a developing ... through the TOC of the Asian Automatic patient billing ... provided. This also provides a glimpse of the segmentation ...
Breaking Biology Technology:Zola P. Horovitz To Retire From GenVec Board 2NDA Partners Appoints Ellen Teplitzky, JD as Director of its Legal Services Practice 2The Asian Automatic patient billing market is estimated to grow to around $463.9 million by 2018 - New Report by MicroMarket Monitor 2The Asian Automatic patient billing market is estimated to grow to around $463.9 million by 2018 - New Report by MicroMarket Monitor 3
... Pharmos Corporation,(Nasdaq: PARS ) announced today that ... from the Company., Mr. Rubino joined Pharmos ... acquisition and the subsequent integration of Vela,Pharmaceuticals completed ... has been focused on key business development priorities ...
... Synthetech, Inc. (OTC,Bulletin Board: NZYM) has earned ... outstanding accomplishments in environmental, health,safety and security ... by,the Synthetic Organic Chemical Manufacturers Association (SOCMA) ... awards are highly,regarded and demonstrate Synthetech,s level ...
... Dec. 18 January 1, 2008 will mark the,ritualistic day ... The New,Year also brings added pressure to smokers as January ... For those resolving to make 2008 the start of a ... Laser Therapy,provided by Achieve Laser, is quickly becoming a very ...
Cached Biology Technology:Pharmos Corporation Announces President & COO Alan L. Rubino to Leave Company 2Synthetech Earns National Recognition for Performance Improvement Program 2Synthetech Earns National Recognition for Performance Improvement Program 3Laser Therapy Gives Smokers Hope for Successful New Year's Resolution 2
(Date:10/16/2014)... October 16, 2014 NXT-ID, Inc. (NASDAQ: ... a biometric authentication company focused on the growing mobile ... technologies including Wocket™, the Smart Wallet, at the 13 ... is a leading global conference on the intersection of ... Mark Anderson , founder and publisher of the ...
(Date:10/15/2014)... from strains of influenza virus increases with the latest ... complacent that the most substantial threats have been identified, ... arise when a new virus strain – against which ... in the human population. There have been five such ... which – the 1918 Spanish Flu – cost 50 ...
(Date:10/15/2014)... The German Gauß-Allianz has admitted Johannes Gutenberg University ... the Rhineland-Palatinate science hub continues to maintain a ... computing. , "The acceptance of Johannes Gutenberg ... Gauß-Allianz is a milestone in the national and ... support. The state of Rhineland-Palatinate can be proud ...
Breaking Biology News(10 mins):NXT-ID Inc. to Present at 13th Annual FiRe Conference 2NXT-ID Inc. to Present at 13th Annual FiRe Conference 3Scientists 'must not become complacent' when assessing pandemic threat from flu viruses 2Johannes Gutenberg University Mainz joins Germany's Gauss-Allianz as a full member 2Johannes Gutenberg University Mainz joins Germany's Gauss-Allianz as a full member 3
... This release is also available in Chinese ... (September 28, 2010) -- The second law of thermodynamics is ... its implicit existential crunch. The tendency of a closed systems ... removed is a popular, if not depressing, "things fall apart" ...
... MT. ROYAL, NJ (September 28, 2010) "Migraine feels ... face," says author Andrew Levy in his interview on the ... of Our Heads". "It,s a metaphysical crisis." In the ... his personal experience with managing the pain of migraine, how ...
... (Sept. 28, 2010) -- A new book, RNA ... reviews our understanding of two RNA worlds: the primordial RNA ... and biocatalyst; and the contemporary RNA world, in which mRNA, ... operate. "[T]he plasticity of RNA stemming from ...
Cached Biology News:Tiny generators turn waste heat into power 2American Migraine Foundation launches new podcast series 2New book reviews ancient and modern worlds of RNA 2
... SYBR Safe DNA gel stain was developed ... than ethidium bromide for staining DNA in agarose ... only less mutagenic than ethidium bromide but SYBR ... of ethidium bromide. SYBR Safe stain comes as ...
... Service enables scientists who do not have access ... to have their biological samples tested for the ... easy as 1-2-3 Chose the analytes ... from the S&S antibody menu. Send your ...
... I nucleic acid gel stain is an ... bright fluorescence when bound to dsDNA and low ... dsDNA in gels using laser scanners or standard ... has also found uses in capillary electrophoresis, real-time ...
... stain has bright fluorescence when bound to dsDNA ... for detecting dsDNA in gels using laser scanners ... nucleic gel acid stain has also found ... bandshift assays. One mL stains 100 minigels. A ...
Biology Products: