Navigation Links
New Drug Application for Tolvaptan, Otsuka's Investigational Novel Oral Treatment for Worsening Heart Failure and Hyponatremia, Accepted by the U.S. Food and Drug Administration
Date:12/21/2007

Otsuka Pharmaceutical Group, which is comprised of 99 companies and approximately 31,000 people around the world. Otsuka and its consolidated subsidiaries earned US $7.2 billion in consolidated annual revenues in fiscal 2006. For additional information, please visit http://www.otsuka.com.

1. Current Proposed PLR, October 19, 2007. Page 1. Supplied by Otsuka.

2. EVEREST, SALT-1, SALT-2

3. SHAPE Survey Results to the General Public, Annual Congress of the

European Society of Cardiology in Vienna, September 2003.

4. ACC News Release, "American College of Cardiology / American Heart

Association guidelines: New heart failure guidelines stress early diagnosis and treatment," August 16, 2005. Accessed at http://www.acc.org/media/releases/highlights/2005/aug05/hf%5Fguideline%5Fupdate.ht m on March 1, 2007.
5. American Heart Association. Heart Disease and Stroke Statistics:

2005Update. Dallas, Tex: American Heart Association; 2005. as cited in

Gheorghiade M, et al. Circulation. 2005;112:3958-3968.

6. Schrier RW, Gheorghiade M, Gross P, et al. Results from the SALT 1 and

2 Trials. Multicenter, Randomized, Placebo-Controlled Trials in

Patients with Euvolemic and Hypervolemic Hyponatremia. Being Presented

at American Heart Association's Scientific Sessions in November 2006.

7. Adrogue HJ, Madias NE. Hyponatremia. NEJM. 2000; 342 (21):1581-1589.

8. Gheorghiade M, Gottlieb SS, Udelson JE, et al. Vasopressin V2 Receptor

Blockade With Tolvaptan Versus Fluid Restriction in the Treatment of

Hyponatremia. AmJCardiol 2006;97:1064-1067.


'/>"/>
SOURCE Otsuka Pharmaceutical Development & Commercialization,Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera
2. Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
3. KineMed to Collaborate With Merck KgaA to Validate New Applications for Drug Development Candidates
4. MichBio Announces Expo Tours; Extends Deadline for Innovator Showcase Applications
5. FDA Accepts ISO-Vorin(TM) New Drug Application Amendment Submitted by Spectrum Pharmaceuticals
6. Isis Announces $4.2 Million in Government Contracts Awarded to Its Ibis Subsidiary for Biodefense Applications Development
7. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
8. Nitecs IND Application for Clinical Development With Lodotra Accepted by the FDA
9. CV Therapeutics Submits Supplemental New Drug Application for Ranexa(R) (ranolazine extended-release tablets)
10. National Stem Cell Holding Announces Patent Application for Newly Discovered Cellular Derived Biomaterials for Anti-Aging Applications
11. Laser Energetics to Integrate BrightStar(TM) Alexandrite Lasers in Medical and Dental Applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... Currently offering a comprehensive portfolio ... Weighing, Rice Lake, and Ohaus, Pipette.com has added ... Sartorius CPA Semi-Micro Balance is ideal for lab ... user-friendly laboratory balance. , Sartorius is a global ... balances are well known for their high performance, ...
(Date:10/22/2014)... , Oct. 22, 2014   Synthetic Biologics, Inc. ... pathogen-specific therapies for serious infections and diseases, announced today ... a Notice of Allowance for a composition of matter ... C. difficile program, SYN-004. This is Synthetic Biologics, ... the U.S. and adds to the Company,s extensive ...
(Date:10/22/2014)... and HONG KONG , Oct. 22, ... therapeutics enterprise, announced today that rare disease expert ... vice president, research. Dr. McKew brings more than two ... positions at the National Institutes of Health, Wyeth Research ... Wyeth). Dr. McKew will lead aTyr,s efforts to expand and ...
(Date:10/20/2014)... Oct. 20, 2014 Asterias Biotherapeutics, Inc. ... has signed a Notice of Grant Award (NGA) ... effective October 1, 2014.  The NGA provides for ... the release of additional grant funds pursuant to ... for clinical development of Asterias, product, AST-OPC1. The ...
Breaking Biology Technology:Pipette.com Launches the Addition of Sartorius CPA Semi-Micro Balance to Their Product Portfolio with Special Promotional Pricing 2Pipette.com Launches the Addition of Sartorius CPA Semi-Micro Balance to Their Product Portfolio with Special Promotional Pricing 3Synthetic Biologics Announces Allowance of Key U.S. Composition of Matter Patent for C. difficile Program 2Synthetic Biologics Announces Allowance of Key U.S. Composition of Matter Patent for C. difficile Program 3Synthetic Biologics Announces Allowance of Key U.S. Composition of Matter Patent for C. difficile Program 4aTyr Pharma Appoints John C. McKew, Ph.D., as Vice President, Research 2aTyr Pharma Appoints John C. McKew, Ph.D., as Vice President, Research 3Asterias Biotherapeutics Announces Notice of Grant Award with CIRM for Phase 1/2a Clinical Trial of AST-OPC1 in Complete Cervical Spinal Cord Injury 2Asterias Biotherapeutics Announces Notice of Grant Award with CIRM for Phase 1/2a Clinical Trial of AST-OPC1 in Complete Cervical Spinal Cord Injury 3Asterias Biotherapeutics Announces Notice of Grant Award with CIRM for Phase 1/2a Clinical Trial of AST-OPC1 in Complete Cervical Spinal Cord Injury 4
... NeoGenomics, Inc. (OTC,Bulletin Board: NGNM) announced today that it ... May 7, 2008., The Company has scheduled a ... May 7, 2008, at 11:00 AM EDT. Interested investors ... minutes prior to the call. A replay of the ...
... Scientific,Corporation (NYSE: BSX ) announced today that ... issued its ruling in an,arbitration between the Company ... pursuant to the 2005 settlement agreement between,the companies, ... various U.S. and European patents held by Medinol. ...
... LEXINGTON, Mass., May 5 Indevus,Pharmaceuticals, Inc. (Nasdaq: ... Phase III extension study of SUPPRELIN(R) LA (histrelin ... of central,precocious puberty or early onset puberty, at ... This study evaluated the two-year,safety and efficacy of ...
Cached Biology Technology:NeoGenomics Schedules Its Q1 2008 Earnings Release for May 7, 2008 2WIPO Panel Rules Boston Scientific Liberte(R) and TAXUS(R) Liberte(R) Stents Do Not Infringe Medinol Patents 2WIPO Panel Rules Boston Scientific Liberte(R) and TAXUS(R) Liberte(R) Stents Do Not Infringe Medinol Patents 3Two Year Study Confirms SUPPRELIN(R) LA Implant Maintains Profound Suppression of Hormones in Children With Premature Onset Puberty 2Two Year Study Confirms SUPPRELIN(R) LA Implant Maintains Profound Suppression of Hormones in Children With Premature Onset Puberty 3Two Year Study Confirms SUPPRELIN(R) LA Implant Maintains Profound Suppression of Hormones in Children With Premature Onset Puberty 4Two Year Study Confirms SUPPRELIN(R) LA Implant Maintains Profound Suppression of Hormones in Children With Premature Onset Puberty 5
(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)... University Mainz (JGU) as a full member, ensuring ... a significant nationwide standing in the field of ... Gutenberg University Mainz as a full member of ... and international competition for the best minds and ... proud that Mainz University has been recognized as ...
(Date:10/15/2014)... Geneticist Fred Alt will be awarded the 44th Rosenstiel ... University for his pioneering research exploring the mechanisms of ... and cancer cells. Alt is the second alumnus to ... the Nobel Prize in 2003. , Alt is the ... Genetics at Harvard Medical School and an investigator at ...
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 3Johannes 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 3Brandeis awards 44th Rosenstiel Award to pioneering geneticist Fred Alt 2
... that the extremely hot, dry and windy conditions on Black ... rolls, -similar to streamers of wind flowing through the air ... the first of its kind to produce such detailed, high-resolution ... for future fire management and warning systems. The work ...
... is a project that will require the cooperation ... and individuals. The 2012 American Chestnut Summit will ... and industry professionals to share the current state ... reintroduction of this species to eastern forests. The ...
... New Rochelle, NY, August 7, 2012The global market value of ... once therapeutics are approved that actually change the course of ... (GEN). The current therapeutic market is valued at $3 to ... or address the symptoms but do not alter the underlying ...
Cached Biology News:Unusual weather events identified during the Black Saturday bushfires 2GEN reports on recent progress in Alzheimer's research 2
Alexa Fluor 647 anti-mouse Qa-2...
... is the first fully genetically encoded fluorescent ... intracellular hydrogen peroxide (H2O2), one of the ... the basis of yellow fluorescent protein inserted ... protein OxyR (OxyR-RD), HyPer demonstrates submicromolar affinity ...
... siSolutions siRNA Custom Synthesis ... effective duplex RNA to knockdown ... 21-mers (19 RNA base pairs ... recently-published 27-mers, or other lengths ...
Alexa Fluor 647 anti-mouse Qa-2...
Biology Products: