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:4/24/2015)... , April 24, 2015  Navitas Life Sciences is ... as Head of Clinical and Regulatory Services. Shalabh is a ... a co-founder and CEO of Kinapse, as well as a ... Logo - http://photos.prnewswire.com/prnh/20150423/201261LOGO ... Tizzard commented "I am delighted to welcome Shalabh into ...
(Date:4/23/2015)... 2015 The Thomas Brain Health ... a groundbreaking pilot study to see if early ... as little as three to six months. , ... nutritional medicine—will aggressively target and simultaneously treat the ... aging brain. These include oxidative stress, neuroinflammation, mitochondrial ...
(Date:4/23/2015)... , April 23, 2015 WuXi PharmaTech (Cayman) ... capability and technology platform company serving the pharmaceutical, biotechnology ... China and the United States ... results for the first quarter of 2015 after the ... 2015 (which will be Thursday morning, May 14, 2015 ...
(Date:4/23/2015)... Glemser Technologies is ... Enterprise Content Division (ECD) Certified Solution Partner to ... for Life Sciences Solution Suite . The accreditation ... to provide life sciences companies of all sizes ... EMC Documentum Solution Suite offers four modules: Quality ...
Breaking Biology Technology:Shalabh Kumar Joins Navitas Life Sciences to Lead their Clinical and Regulatory Services Teams 2New Study Looks to Reverse Alzheimer’s Disease 2New Study Looks to Reverse Alzheimer’s Disease 3WuXi PharmaTech Schedules First-Quarter 2015 Earnings Release 2WuXi PharmaTech Schedules First-Quarter 2015 Earnings Release 3Glemser Earns Accreditation for Life Sciences Solution Suite 2
... 3SBio Inc.,(Nasdaq: SSRX ) ("3SBio" or ... focused on researching, developing, manufacturing and,marketing biopharmaceutical ... board of directors has approved a share ... 3SBio to purchase up to US$20 million ...
... Genomas(R), a,biomedical company advancing DNA-guided medicine and ... Phase I-II Small,Business Innovation Research (SBIR) Grant totaling ... Statin Safety and Efficacy," was,awarded by the National ... are the most prescribed drugs in the world. ...
... to Attend April Meeting,in St. Louis, DANBURY, ... (SBS) today announced its outstanding roster of,keynote speakers ... be held,April 6-10 at America,s Center in St. ... and biotech industries from around the world are,expected ...
Cached Biology Technology:3SBio Inc. Approves Share Repurchase Program 2Genomas Awarded $1.2 Million NIH SBIR Grant to Develop DNA-Guided System for Management of Statin Therapy 2Society for Biomolecular Sciences Announces 2008 Conference Speaker Line-up 2
(Date:3/23/2015)... , March 23, 2015  In the 2014 fiscal ... case conviction losses. This figure accounts for a fraction ... to The Nilson Report, exceeds $11 billion globally. The ... after a crime has occurred. Investor Mark Saint ... expert Joe Paolella partnered to administer the ...
(Date:3/20/2015)... -- NXT-ID, Inc. (NASDAQ: NXTD ) ("NXT-ID" or ... growing mobile commerce market, announces its biometric payment technology, ... featured in 2015 "I Want That" International CES Special, ... the DIY Network.   DIY,s "I Want ... site of the 2015 International CES for a firsthand ...
(Date:3/17/2015)... , March 17, 2015 ... company specializing in clinical study management systems, is ... in attendance at ARENA,s Outsourcing in Clinical Trials ... This event provides an excellent forum for MedNet ... flexible and affordable software-as-a-service (SaaS) eClinical technology platform. ...
Breaking Biology News(10 mins):Polygraph Test Now Used to Protect Investors From Fraud 2Polygraph Test Now Used to Protect Investors From Fraud 3NXT-ID's Wocket Biometric Smart Wallet to Air on "I Want That" International CES Special 2NXT-ID's Wocket Biometric Smart Wallet to Air on "I Want That" International CES Special 3Connect With MedNet Solutions At Outsourcing In Clinical Trials Southeast 2
... PITTSBURGHCarnegie Mellon University,s John Kitchin was awarded $750,000 ... of Energy for developing new materials for producing ... was elated to hear that my research had been ... professor in Chemical Engineering at Carnegie Mellon. "This ...
... distinctive red soils could play a part in the formation ... off east coast beaches in summer., A QUT team of ... gives our iron-rich soil its red colour, reaches water to ... a foul smell, but also make our eyes sting, cause ...
... This release is available in German . ... decreased over recent decades. In fact, the number of beekeepers has ... the result of a study that has now been published by ... provided an overview of the problem of bee colony decline at ...
Cached Biology News:Carnegie Mellon's John Kitchin receives early career award 2Is iron from soil a factor in algal blooms? 2Fewer honey bee colonies and beekeepers throughout Europe 2Fewer honey bee colonies and beekeepers throughout Europe 3
ma. plate stack height 70mm...
Buckets for tube holder inserts...
...
... MBS Start up kit. Includes configured Laptop ... of 2 MultiBlock satellite thermal cyclers ... User friendly software. Store/track run ... heated lid. Outstanding uniformity. Advanced ...
Biology Products: