Navigation Links
FDA Approves Lilly's Zyprexa for Two Adolescent Indications
Date:12/4/2009

INDIANAPOLIS, Dec. 4 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) today approved Zyprexa® (olanzapine) in tablet form as an option for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old.

The updated Zyprexa label states that clinicians should take into consideration the increased potential for weight gain and hyperlipidemia in adolescents compared to adults and the potential for long-term risks, which in many cases, may lead them to consider prescribing other drugs first in adolescents. Compared to patients from adult clinical trials, adolescents were also likely to experience increased sedation and greater increases in prolactin levels and hepatic transaminase (liver enzymes) levels. The recommended starting dose for adolescents is lower than that for adults.

An FDA Psychopharmacologic Drug Advisory Committee (PDAC) met in June and discussed the difficulties of diagnosing and treating these conditions in adolescents. The Zyprexa label provides additional guidance to physicians that medication therapy for pediatric schizophrenia or bipolar I disorder should be initiated only after a thorough diagnostic evaluation and careful consideration of the risks associated with medication treatment.

The updated Zyprexa label also highlights the need for a comprehensive treatment program in pediatric patients and recommends that Zyprexa be used as part of a "total treatment program for pediatric patients with schizophrenia and bipolar I disorder," which may include psychological, educational and social interventions.

This approval follows a favorable vote regarding the safety and efficacy of Zyprexa from the FDA PDAC in June on Lilly's supplemental New Drug Applications for these indications. The Committee examined findings from two pivotal clinical trials: one six-week trial in adolescents with sch
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder
2. FDA Approves Use of Roche Test to Screen Source Plasma for HIV, Hepatitis B Virus and Hepatitis C Virus
3. FDA Approves ZEGERID OTC(TM) for Over-the-Counter Treatment of Frequent Heartburn
4. FDA Approves Cymbalta(R) for Maintenance Treatment of Generalized Anxiety Disorder
5. FDA Approves Agriflu Seasonal Influenza Vaccine
6. FDA Approves Lysteda to Treat Heavy Menstrual Bleeding
7. Rogan-Delft Approves Matrox Xenia Series for Use With Zillion Suite
8. FDA approves GlaxoSmithKlines VOTRIENT(TM) for advanced renal cell cancer
9. FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use
10. FDA Approves New Treatment for Advanced Form of Kidney Cancer
11. FDA Approves Elitek(R) (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... Jan. 14, 2014  Luminex Corporation (Nasdaq: LMNX ) ... fourth quarter of 2013 on Monday, February 3, 2014. A ... the close of trading. (Logo: http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO ... discuss the operating highlights and financial results for the fourth ...
(Date:1/14/2014)... , Jan. 14, 2014 /PRNewswire-iReach/ -- Acumed,s new SLIC ... guide with accompanying instrumentation to place and insert the ... the soft tissue (e.g. ligament) repair or reconstruction as ... heals. (Photo: http://photos.prnewswire.com/prnh/20140114/MN45636 ) ...
(Date:1/14/2014)... 2014   Oligomerix, Inc. , a privately held company ... disease (AD) and related neurodegenerative disorders, announced today the ... NY as of January 15, 2014 and ... York Medical College. Oligomerix, which is focused ...
Breaking Medicine Technology:Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3Oligomerix Relocates Corporate Headquarters and Secures Additional Laboratory Space from New York Medical College 2
... Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ), Eli ... Inc. (Nasdaq: ALKS ) today announced that the ... response letter regarding the New Drug Application (NDA) for BYDUREON™ ... complete response letter the FDA requested a thorough QT (tQT) ...
... , Matt Perkins, chief technology officer and senior vice ... provider of ZigBee-based real-time location solutions ( RTLS ) ... real-time location and condition sensing and ZigBee -based ... and beyond at the 2010 Mobile Health Expo.  WHAT: ...
Cached Medicine Technology:Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 2Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 3Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 4Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 5Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 6Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 7Awarepoint to Present 'ZigBee-based Wireless Sensor Networks for Use in Acute Care Hospitals and Beyond' at Mobile Health Expo Speaker Session 2Awarepoint to Present 'ZigBee-based Wireless Sensor Networks for Use in Acute Care Hospitals and Beyond' at Mobile Health Expo Speaker Session 3
(Date:4/17/2014)... Council scientists and their partners have found that their ... the transmission of multiple sexually transmitted infections (STIs) in ... simplex virus 2 (HSV-2), and human papillomavirus (HPV). The ... gel is effective against multiple strains of HIV, and ... all three viruses of at least eight hours prior ...
(Date:4/17/2014)... and alleviates muscle soreness after exercise, according to ... Illinois at Chicago. , The study, reported online ... of Physical Medicine and Rehabilitation , also showed ... had not exercised, suggesting that massage has benefits ... activity. , Improved circulation and relief of muscle ...
(Date:4/17/2014)... 94 per cent of Canadians surveyed said they would ... a specific number of genetic conditions, only 80 per ... screening that would sequence their newborns, genomes.,Most newborns in ... first day or two of life in which a ... and tested for about five to 54 conditions, depending ...
(Date:4/17/2014)... its status as the leading weapon against the deadly ... with new research indicating it simply needs to be ... of the cheap anti-malarial drug chloroquine in treating and ... more than half a million people each year around ... developed resistance to chloroquine, but research carried out at ...
(Date:4/16/2014)... , PHOENIX, Ariz. April 15, 2014 The ... Arizona philanthropists at their annual Founders Dinner for their ... cancer. The event took place March 28 in Scottsdale. ... & Catherine Ivy Foundation, received TGen,s John S. McCain ...
Breaking Medicine News(10 mins):Health News:Animal study provides first evidence that gel can prevent multiple virus transmission in vagina/rectum 2Health News:Massage therapy improves circulation, eases muscle soreness 2Health News:Researcher looks at public perceptions around newborn testing 2Health News:Researcher looks at public perceptions around newborn testing 3Health News:Scientists find new way to fight malaria drug resistance 2Health News:TGen honors Catherine Ivy and Craig Jackson with Leadership; Collaborative Spirit awards 2
... work better in protecting children from flu if they included ... Louis University research has found. "Adding a second influenza ... some of the guesswork out of strain selection and help ... M.D., lead investigator and director of the Center for Vaccine ...
... ... Wigix Inc.’s subsidiary, ddku.com, affording it an end to end marketing platform in China. ... Oakland, CA ... has acquired a Shanghai-based business process outsourcing company, Mag2U, to enhance DDKU’s growing internet ...
... diagnosis should consider genetic testing, experts say , TUESDAY, April ... age 55 who also have a genetic mutation that boosts ... cancer in the opposite breast than are women who don,t ... Risk increased fourfold for these women, who carry a mutation ...
... (Baltimore, MD) Today, the Interactive Autism Network ... project, announces results of the Grandparents of Children ... one-third of grandparents who participated were the first ... its launch in 2007, the IAN Project has ...
... April, 2010 The global nursing shortage is due in ... to a phenomenon known as nurse migration, where nurses leave ... International Council of Nurses (ICN) and the Honor Society of ... Foundation, will conduct the Global Summit on Nurse Faculty Migrationa ...
... Attention-deficit/hyperactivity disorder (ADHD) is one of the most common ... ADHD are excessively restless, impulsive, and distractible and experience ... are a common theme for ADHD symptoms. These ... or a combination of the two. In ...
Cached Medicine News:Health News:Building a better flu vaccine: Add second strain of influenza B 2Health News:Wigix Acquires Mag2U, A Leading Business Process Outsourcing Company 2Health News:Wigix Acquires Mag2U, A Leading Business Process Outsourcing Company 3Health News:Gene Mutations Up Risk for Cancer in Opposite Breast 2Health News:Gene Mutations Up Risk for Cancer in Opposite Breast 3Health News:New survey finds grandparents play key role in lives of children with autism 2Health News:New survey finds grandparents play key role in lives of children with autism 3Health News:International summit seeks solutions to global shortage of nursing faculty 2Health News:Synergy between behavioral and pharmacologic interventions for ADHD 2
... single-lead principle has been applied to cardiac resynchronization ... which consists of the Tupos LV/A+ and the ... surgery and the risk of complications. The ICD ... via a single lead. The atrial input stage ...
... ICD cardiac resynchronization and ICD device offers ... The unit's RV only sensing provides no ... LV depolarizations, eliminating this cause of inappropriate ... LV separation for optimized hemodynamics. Proven PR ...
... The Medtronic InSync II Marquis ... and ICD therapy. Cardiac resynchronization benefits ... adapt pacing outputs to unique patient ... monitoring functions that help physicians manage ...
... Guidant's Contak Renewal 2 cardiac resynchronization ... therapy for the treatment of heart ... the right and left ventricles or ... contractions. The device provides ventricular tachyarrhythmia ...
Medicine Products: