Navigation Links
U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
Date:2/29/2008

.D., Chief Executive Officer, President and Chief Operating Officer, Otsuka Pharmaceutical Development and Commercialization, Inc. "The approval of this new indication for ABILIFY provides clinicians with expanded treatment options that can help address the therapeutic needs of this population."

"We are committed to developing innovative new medicines to their fullest potential," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. "Expanding the clinical use of an important therapy such as ABILIFY gives pediatric patients with Bipolar I Disorder and their caregivers a new treatment option in their fight against this serious disease."

Clinical Trial Design and Findings

These findings are from a four-week, multicenter, randomized, double-blind, placebo-controlled study, which evaluated the efficacy and safety of ABILIFY in 296 pediatric patients (10 to 17 years old) with a DSM-IV diagnosis of Bipolar I Disorder, manic or mixed episodes, with or without psychotic features. Diagnosis was made by a trained child and adolescent psychiatrist and confirmed by a separate diagnostic interview. This study was conducted on an outpatient basis with the possibility of inpatient hospitalization, as needed. This clinical trial was sponsored by Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ) with enrollment at 54 U.S. centers.

After a screening period of up to four weeks, pediatric patients (10 to 17 years old) who scored greater than or equal to 20 on the Y-MRS* were randomly assigned to receive one of two fixed doses of ABILIFY [10 mg/day (n=98) or 30 mg/day (n=99)] or placebo (n=99). ABILIFY was initiated at a starting dose of 2 mg/day and titrated to the target dose of 10 mg/day or 30 mg/day.

The primary efficacy endpoint was the mean change in the Y-MRS Total Score f
'/>"/>

SOURCE Otsuka Pharmaceutical Co., Ltd.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Biological Psychiatry Publishes Study Showing VYVANSE Demonstrated Significant Efficacy for Treatment of ADHD for up to 12 Hours After Administration
2. Supplemental New Drug Application for PREZISTA(TM) Submitted to U.S. Food and Drug Administration
3. Northwestern Offers Clinical Research and Regulatory Administration Graduate Certificate Program
4. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
5. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
6. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
7. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
8. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
9. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
10. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
11. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/1/2014)... Dyadic International, Inc. ("Dyadic") (OTCQX: DYAI), a ... used to develop, manufacture and sell enzymes and other ... enzyme industries, announced today that it will report its ... 2014 after market close on Thursday, August 14, 2014 ... 5:00 p.m. Eastern Time to discuss those results. ...
(Date:7/31/2014)... Indien, August 1, 2014 ... Inc. gaben heute bekannt, vor kurzem für ... zur Schmerzbehandlung nach chirurgischen Eingriffen eine kommerzielle ... der Europäischen Union und weiterer europäischer Länder ... und mit Ropivacain gefüllte OneDose ReadyfusOR später ...
(Date:7/31/2014)... Calif., July 31, 2014 STAAR Surgical Company ... and marketer of implantable lenses and delivery systems for ... ended July 4, 2014 of $20.0 million, a 10% ... of 2013. On a constant currency basis, revenues grew ... the second quarter of 2013.  The effect of foreign ...
Breaking Medicine Technology:Dyadic International To Announce Second Quarter 2014 Financial Results And Host Conference Call On Thursday, August 14, 2014 2Dyadic International To Announce Second Quarter 2014 Financial Results And Host Conference Call On Thursday, August 14, 2014 3Cipla und BioQuiddity geben EU-Geschäftspartnerschaft für OneDose-ReadyfusOR zur Schmerzbehandlung nach chirurgischen Eingriffen bekannt 2Cipla und BioQuiddity geben EU-Geschäftspartnerschaft für OneDose-ReadyfusOR zur Schmerzbehandlung nach chirurgischen Eingriffen bekannt 3STAAR Surgical Reports 10% Second Quarter Revenue Growth 2STAAR Surgical Reports 10% Second Quarter Revenue Growth 3STAAR Surgical Reports 10% Second Quarter Revenue Growth 4STAAR Surgical Reports 10% Second Quarter Revenue Growth 5STAAR Surgical Reports 10% Second Quarter Revenue Growth 6STAAR Surgical Reports 10% Second Quarter Revenue Growth 7STAAR Surgical Reports 10% Second Quarter Revenue Growth 8STAAR Surgical Reports 10% Second Quarter Revenue Growth 9STAAR Surgical Reports 10% Second Quarter Revenue Growth 10STAAR Surgical Reports 10% Second Quarter Revenue Growth 11STAAR Surgical Reports 10% Second Quarter Revenue Growth 12STAAR Surgical Reports 10% Second Quarter Revenue Growth 13STAAR Surgical Reports 10% Second Quarter Revenue Growth 14STAAR Surgical Reports 10% Second Quarter Revenue Growth 15STAAR Surgical Reports 10% Second Quarter Revenue Growth 16STAAR Surgical Reports 10% Second Quarter Revenue Growth 17STAAR Surgical Reports 10% Second Quarter Revenue Growth 18STAAR Surgical Reports 10% Second Quarter Revenue Growth 19STAAR Surgical Reports 10% Second Quarter Revenue Growth 20STAAR Surgical Reports 10% Second Quarter Revenue Growth 21STAAR Surgical Reports 10% Second Quarter Revenue Growth 22STAAR Surgical Reports 10% Second Quarter Revenue Growth 23STAAR Surgical Reports 10% Second Quarter Revenue Growth 24STAAR Surgical Reports 10% Second Quarter Revenue Growth 25STAAR Surgical Reports 10% Second Quarter Revenue Growth 26STAAR Surgical Reports 10% Second Quarter Revenue Growth 27STAAR Surgical Reports 10% Second Quarter Revenue Growth 28STAAR Surgical Reports 10% Second Quarter Revenue Growth 29STAAR Surgical Reports 10% Second Quarter Revenue Growth 30STAAR Surgical Reports 10% Second Quarter Revenue Growth 31
... 2010 /PRNewswire-- Sangart, Inc., a global biopharmaceutical ... to enhance the perfusion and oxygenation of ischemic ... gas delivery, today announced that its investigational biopharmaceutical ... by the U.S. Food and Drug Administration (FDA) ...
... A new electronic health record (EHR) safety reporting ... not-for-profit organization composed of medical society and professional liability ... Network. EHRevent.org establishes a national system where ... related to the implementation and use of EHRs. ...
Cached Medicine Technology:Sangart, Inc. Receives U.S. Orphan Drug Designation for use of MP4CO in Patients with Sickle Cell Disease 2Sangart, Inc. Receives U.S. Orphan Drug Designation for use of MP4CO in Patients with Sickle Cell Disease 3New National Electronic Health Record Safety System Launched 2New National Electronic Health Record Safety System Launched 3New National Electronic Health Record Safety System Launched 4New National Electronic Health Record Safety System Launched 5New National Electronic Health Record Safety System Launched 6
(Date:8/2/2014)... According to the Girl Gets Ring System review ... for women. The book consists of dating tips and tricks ... book also teaches women how to deal with relationship ... its review that this book is divided into 10 chapters ... Story? ,     Chapter 2 – How A Traffic Light ...
(Date:8/2/2014)... On July 21, 2014, the Johns Hopkins Health ... settle the class action lawsuit filed October 24, ... 24-C-13-001041 MM, on behalf of thousands of women who allegedly ... According to The Baltimore Sun , the $190 ... a physician accused of sexual misconduct. , An investigation prompted ...
(Date:8/1/2014)... The successful development of C60F projects is of ... Automobile Co.,LTD. As early as the very beginning of ... excellent team to develop a comprehensive plan to carry ... The company’s vice president Liming Yang and some of ... the specific arrangement and the supervision of the project ...
(Date:8/1/2014)... of Medicine in St. Louis helps explain why brain ... more harmful than similar tumors in females. For example, ... twice as often in males, who suffer greater cognitive ... , The researchers found that retinoblastoma protein (RB), a ... active in male brain cells than in female brain ...
(Date:8/1/2014)... (HealthDay News) -- The U.S. Food and Drug Administration ... Jardiance, to help fight type 2 diabetes. ... existing treatment regimens to control blood sugar levels in ... of the Office of Drug Evaluation II in the ... an agency statement. The FDA also recommended that ...
Breaking Medicine News(10 mins):Health News:Girl Gets Ring System Review Exposes Jonathan Green's Dating Guide For Women – Vkool.com 2Health News:Girl Gets Ring System Review Exposes Jonathan Green's Dating Guide For Women – Vkool.com 3Health News:Baltimore Lawyer Steven H. Heisler Urges Victims of OB/GYN Misconduct to Speak Out 2Health News:Baltimore Lawyer Steven H. Heisler Urges Victims of OB/GYN Misconduct to Speak Out 3Health News:FODAY Automobile Company Is Now Working On The C60F FODAY Project 2Health News:Study reveals one reason brain tumors are more common in men 2Health News:FDA Approves New Type 2 Diabetes Drug 2
... House ceremony next month, Thomas L. Kash, PhD, assistant professor ... for Alcohol Studies at the University of North Carolina at ... Career Award for Scientists and Engineers (PECASE). , This is ... science and engineering professionals in the early stages of their ...
... in the October 2011 issue of The FASEB ... "healthy" ingredient in red wine, stops breast cancer cells ... This discovery, made by a team of American and ... is able to counteract the malignant progression since it ...
... By Serena Gordon HealthDay Reporter , WEDNESDAY, Sept. 28 ... advanced Alzheimer,s or other form of severe dementia will be shuttled ... months of life, a new U.S. study shows. The ... Depending on where a patient lives, as many as ...
... the British Journal of Sports Medicine * highlights the injury ... chance of a school player suffering an injury during a single ... research, could be as high as 90 per cent. The ... City University say there is an urgent need to inform children, ...
... with dementia can still make decisions in their everyday lives ... as their condition advances. This is one of the preliminary ... and Social Research Council (ESRC) into how married couples living ... study is investigating how couples make decisions over issues such ...
... dose of the hallucinogen psilocybin, the active ingredient in ... measureable personality change lasting at least a year in ... new study, according to the Johns Hopkins researchers who ... part of the personality known as openness, which includes ...
Cached Medicine News:Health News:UNC researcher to receive highest US honor for early career science professionals 2Health News:End-Stage Alzheimer's Patients Often Hospitalized Unnecessarily 2Health News:End-Stage Alzheimer's Patients Often Hospitalized Unnecessarily 3Health News:Academic issues warning on schoolboy rugby 2Health News:Living with dementia and making decisions 2Health News:Single dose of hallucinogen may create lasting personality change 2Health News:Single dose of hallucinogen may create lasting personality change 3
The Bofor acetabular revision cup addresses cases of severe acetabular destruction....
The Protract stem offers a press-fit option which will allow choice of standard or lateralized neck offsets while keeping a consistent leg length....
Performa uncemented stem....
M2 cemented hip stem....
Medicine Products: