Navigation Links
FDA Approves SAMSCA(TM) (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia
Date:5/21/2009

Once-Daily SAMSCA Increases Serum Sodium Levels Through Increase in Free Water Clearance

TOKYO and PRINCETON, N.J., May 21 /PRNewswire/ -- Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) announced today that the U.S. Food and Drug Administration (FDA) has approved SAMSCA(TM) (tolvaptan) as the only oral selective vasopressin antagonist for the treatment of patients with clinically significant hypervolemic and euvolemic hyponatremia (serum sodium less than 125 mEq/L, or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) including patients with heart failure, cirrhosis, and the syndrome of inappropriate anti-diuretic hormone (SIADH). Patients requiring urgent treatment to raise serum sodium to prevent or to treat serious neurological deficits should not be treated with SAMSCA. Additionally, it has not been established that raising serum sodium with SAMSCA provides a symptomatic benefit to patients. SAMSCA, an oral vasopressin V2-receptor antagonist, will be commercialized in the United States by Otsuka America Pharmaceutical, Inc. (OAPI).

Once-daily SAMSCA has been shown to significantly raise serum sodium concentrations in as early as 8 hours, and the change was maintained for 30 days. Exposure and response to SAMSCA are similar in patients with a creatinine clearance of 10-79 mL/min and in patients without renal impairment; thus no dosage adjustment is necessary. SAMSCA has not been evaluated in patients with creatinine clearance less than 10 mL/min or in patients undergoing dialysis.

"The approval of SAMSCA marks a significant milestone for Otsuka," said Taro Iwamoto, Ph.D., President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "Otsuka Pharmaceutical Co., Ltd. has continued its commitment to create innovative products for cardiovascular, respiratory, digestive and infectious dise
'/>"/>

SOURCE Otsuka Pharmaceutical Co., Ltd.; Otsuka America Pharmaceutical, Inc.; Otsuka Pharmaceutical Development & Commercialization, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine news :

1. FDA Approves First Anti-Psychotic for Kids
2. FDA Approves New Roche West Nile Virus Blood Screening Test
3. FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk
4. FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis
5. FDA Approves SOMA(R) (carisoprodol) 250 mg
6. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
7. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
8. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
9. ABIH Approves Certification Credit for SSPC Training Courses
10. FDA Approves REALIZE(TM) Adjustable Gastric Band for Morbid Obesity
11. FDA Approves New Flu Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... AngelWeddingDress, the premier women’s dress supplier, has ... View website of AngelWeddingDress.com to find more ... dresses online for a bridal party. AngelWeddingDress offers a ... them. Its maternity wedding dresses are specially designed for ...
(Date:1/22/2015)... Autocarinsurancebest.com has released a new blog post explaining the ... . , Auto insurance quotes help many drivers find ... necessary to call an agent or visit an agency for ... single website: http://autocarinsurancebest.com/ . , Every business who relies ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Yesterday, ... Bonilla (D-Concord) and Kristin Olsen (R-Modesto) were honored ... leadership in advancing biotechnology, biomedical science, medical device ... Olsen each received the “2014 Life Sciences Champion” ...
(Date:1/22/2015)... EBSCO Information Services (EBSCO) and ... relationship in an effort to further promote visibility and adoption ... has long made AMA journals available via its subscription services, ... JAMA Network. , Long known as both a ...
(Date:1/22/2015)... Richmond, VA (PRWEB) January 22, 2015 ... the power at the Science Museum of Virginia. Wicked ... 24. , Wicked Plants unearths 75 poisonous, carnivorous and ... traverse through each room to uncover the biochemical, physical ...
Breaking Medicine News(10 mins):Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:EBSCO Expands Partnership with the American Medical Association 2Health News:EBSCO Expands Partnership with the American Medical Association 3Health News:EBSCO Expands Partnership with the American Medical Association 4Health News:Wicked Plants are taking over the Science Museum of Virginia 2
... HealthDay Reporter , FRIDAY, Jan. 28 (HealthDay ... a decision by a drug manufacturer to halt production ... medication,s use in lethal injections in prison executions. ... Pentothal (sodium thiopental) at its plant in Italy, but ...
... cancer surgery may help activate the body,s immune response ... lowering mood disturbance, according to a new study by ... Center. The study is published in the ... It,s the first to examine the effects pre-surgery stress ...
... Dennis Thompson HealthDay Reporter , FRIDAY, Jan. 28 ... mantra for those who think people have become too reliant ... agree with the sentiment. They,re concerned that doctors are ... hands-on physical examination in favor of newfangled tests and scans. ...
... A team of researchers led by Vicente Gilsanz, ... Institute of Children,s Hospital Los Angeles, determined that the onset ... density, or bone strength. Length of puberty did not ... leads to osteoporosis, resulting in bones becoming increasingly brittle and ...
... Reporter , FRIDAY, Jan. 28 (HealthDay News) -- People facing ... by lack of control -- with doctors poking and prodding ... Hospice care, however, can give back some control over ... and helping both the dying person and the person,s family ...
... The Office of Naval Research,s (ONR) TechSolutions department is ... later this year new protective eyewear that will eliminate ... colored lenses to accommodate differences in light levels. ... transitional lenses commonly found at an optometrist,s office. "Transition ...
Cached Medicine News:Health News:Will Loss of Lethal Injection Drug Harm Surgical Patients? 2Health News:Will Loss of Lethal Injection Drug Harm Surgical Patients? 3Health News:Pre-surgical stress management boosts immune function, lowers mood disturbance in prostate cancer patients 2Health News:Pre-surgical stress management boosts immune function, lowers mood disturbance in prostate cancer patients 3Health News:Calls Go Out to Revive the Traditional Physical 2Health News:Calls Go Out to Revive the Traditional Physical 3Health News:Researchers discover age of onset of puberty predicts adult osteoporosis risk 2Health News:More People Choosing Hospice at Life's End 2Health News:More People Choosing Hospice at Life's End 3Health News:ONR's TechSolutions providing SEALs with new glasses that change lens color on the fly 2
(Date:1/23/2015)... , Jan. 23, 2015 Gem Pharmaceuticals announced today ... been enrolled into the Company,s Phase 2 clinical trial. ... of Gem,s lead compound, GPX-150 (an investigational medication), in ... metastatic disease. Logo - http://photos.prnewswire.com/prnh/20150123/170966LOGO ...
(Date:1/22/2015)... Colo. , Jan. 22, 2015  BiOptix is pleased ... as Vice President of Chemistry and Biochemistry. Scott joins ... Pharmaceuticals, AstraZeneca Pharmaceuticals, and Amgen throughout the course of ... development. "Scott is a nationally recognized thought ...
(Date:1/22/2015)... Calif. , Jan. 22, 2015  Amgen (NASDAQ: AMGN ... full year 2014 financial results on Tuesday, Jan. 27, 2015, after ... followed by a conference call with the investment community at 2 ... Robert A. Bradway , chairman and chief executive officer, and other ...
Breaking Medicine Technology:Gem Pharmaceuticals Announces Enrollment of Initial Patients in its Phase 2 Clinical Trial to Assess the Efficacy and Safety of GPX-150 in Sarcoma Patients 2BiOptix Expands Leadership Team with the Appointment of Dr. Scott Klakamp as Vice President of Chemistry and Biochemistry 2Amgen Announces Webcast of 2014 Fourth Quarter and Full Year Financial Results 2
... Late Stage Clinical Therapeutic Cancer... -- TUEBINGEN, Germany, September 21, 2010 ... ... ... ,; var first_result; // Results are keyed by longUrl, so we need to grab the first one. ...
... Inc., today announced that it reported positive preclinical ... Association for the Study of Diabetes (EASD).  CCX140, ... the chemokine receptor CCR2, improved metabolic function while ... in an animal model, and was well tolerated ...
Cached Medicine Technology:immatics Raises EUR54 Million to Advance its Late Stage Clinical Therapeutic Cancer Vaccine Portfolio 2immatics Raises EUR54 Million to Advance its Late Stage Clinical Therapeutic Cancer Vaccine Portfolio 3immatics Raises EUR54 Million to Advance its Late Stage Clinical Therapeutic Cancer Vaccine Portfolio 4immatics Raises EUR54 Million to Advance its Late Stage Clinical Therapeutic Cancer Vaccine Portfolio 5immatics Raises EUR54 Million to Advance its Late Stage Clinical Therapeutic Cancer Vaccine Portfolio 6immatics Raises EUR54 Million to Advance its Late Stage Clinical Therapeutic Cancer Vaccine Portfolio 7immatics Raises EUR54 Million to Advance its Late Stage Clinical Therapeutic Cancer Vaccine Portfolio 8immatics Raises EUR54 Million to Advance its Late Stage Clinical Therapeutic Cancer Vaccine Portfolio 9immatics Raises EUR54 Million to Advance its Late Stage Clinical Therapeutic Cancer Vaccine Portfolio 10ChemoCentryx Reports Positive Results and Completion of Phase I Clinical Studies of Novel CCR2 Antagonist, CCX140, at the European Association for the Study of Diabetes (EASD) 2ChemoCentryx Reports Positive Results and Completion of Phase I Clinical Studies of Novel CCR2 Antagonist, CCX140, at the European Association for the Study of Diabetes (EASD) 3ChemoCentryx Reports Positive Results and Completion of Phase I Clinical Studies of Novel CCR2 Antagonist, CCX140, at the European Association for the Study of Diabetes (EASD) 4
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: