HOME >> MEDICINE >> NEWS
Abilify sNDA for pediatric patients with schizophrenia accepted for priority FDA review

(TOKYO, JAPAN and PRINCETON, NJ, JUNE 5, 2007) Otsuka Pharmaceutical Co, Ltd., and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority (six month review target) review the supplemental New Drug Application (sNDA) of the atypical antipsychotic ABILIFY (aripiprazole) for the treatment of pediatric patients (13-17 years old) with schizophrenia. This sNDA is based on data from a six-week, double-blind, randomized, placebo-controlled study, sponsored by Otsuka Pharmaceutical Co., Ltd., and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ) evaluating the use of ABILIFY in 302 ethnically diverse pediatric patients (ages 13-17) and was conducted at 101 centers in 13 countries.


'"/>

Contact: Debra Kaufmann
debra.kaufmann@otsuka.com
240-683-3568
Otsuka America Pharmaceutical, Inc.
5-Jun-2007


Page: 1

Related medicine news :

1. 1 of 2 pediatric kidney disease research centers in world established
2. Wireless technology shows promise in diagnosing pediatric intestinal disease
3. Study: Who claims to be a pediatrician?
4. Help for pediatricians in treating behavioral health problems only partially successful
5. Most pediatric chemotherapy mistakes reach patients
6. UCLA pediatrician honored with prestigious achievement award
7. Childrens Hospital and Pitt lead national trial of hypothermia to treat pediatric brain injury
8. Procedural changes may reduce cardiac arrests outside pediatric ICUs
9. New, less painful wound treatment for pediatric patients
10. Study in recent issue of Clinical Pediatrics helps pediatricians to understand discipline practices
11. Columbia pediatricians, Anne Gershon and Richard Polin, awarded top honors

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/12/2017)... ... 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), one of the ... new design of the shoulder pad. The shoulder pad provides optimal support and ... pain while using cold therapy. By utilizing ice and water that is circulated from ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... has recently contributed a medical article to the newly revamped Cosmetic Town ... article spotlights the hair transplant procedure known as Follicular Unit Extraction ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at Children’s ... the 49th Congress of the International Society of Paediatric Oncology (SIOP) Oct. ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, ...
(Date:10/12/2017)... RAPIDS, Mich. (PRWEB) , ... October 12, 2017 ... ... Wellness, has been named one of Michigan’s 2017 Best and Brightest in Wellness® ... and Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. ...
Breaking Medicine News(10 mins):
(Date:9/28/2017)... 28, 2017 Hill-Rom Holdings, Inc. (NYSE: HRC), ... call and webcast on Friday, November 3, 2017, beginning ... ending at approximately 8:30 a.m. (CDT) / 9:30 a.m. ... 2017 financial performance and guidance for 2018, Hill-Rom executives ... enhance operational performance, and long-range financial outlook through 2020. ...
(Date:9/27/2017)... Sept. 27, 2017  Commended for their devotion to personalized ... Ranked as number one in the South Florida Business Journal,s ... Inc. 5000 yearly list, the national specialty pharmacy has found ... Bardisa will soon be honored by SFBJ as the ... Set to receive his award in October, Bardisa ...
(Date:9/25/2017)... 25, 2017   Montrium , an industry ... today—from the IQPC Trial Master Files & Inspection ... that EastHORN Clinical Services has selected eTMF ... TMF management. EastHORN, a leading European contract research ... increase transparency to enable greater collaboration with sponsors, ...
Breaking Medicine Technology:
Cached News: