Navigation Links
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)
Date:2/6/2009

TITUSVILLE, N.J., Feb. 6 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced that the company has submitted multiple applications to the U.S. Food and Drug Administration (FDA) which, if approved, would broaden treatment options for patients diagnosed with schizophrenia or schizoaffective disorder.

Earlier this week, the company submitted its response to the FDA complete response letter for paliperidone palmitate, received in August 2008. Paliperidone palmitate is an investigational once-monthly atypical antipsychotic injection which, if approved, will be indicated for the acute and maintenance treatment of schizophrenia.

The company also submitted two supplemental new drug applications (sNDAs) to the FDA requesting approval for the use of INVEGA tablets for the treatment of schizoaffective disorder as monotherapy and for use in combination with antidepressants and/or mood stabilizers. The sNDA submissions include data from two international, 6-week double-blind placebo-controlled studies that evaluated the efficacy and safety of INVEGA in patients with schizoaffective disorder. If approved by the FDA, INVEGA would be the only medication indicated to treat the condition.

Patients with schizoaffective disorder experience the psychotic symptoms of schizophrenia, such as hallucinations or delusions, as well as mania and/or depression. Because of the similarity in symptoms, schizoaffective disorder is sometimes misdiagnosed as schizophrenia or bipolar disorder. For patients who frequently use mental health services, schizophrenia and schizoaffective disorder may account for approximately 32% and 24% of cases respectively.(i)

INVEGA, an atypical antipsychotic medication, was first approved in the U.S. in December 2006 and is marketed by Janssen. It is approved for the acute and maintenance treatment of schizophrenia in the U.S. an
'/>"/>

SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Johnson & Johnson to Provide Webcast Presentation of Tapentadol Phase 3 Clinical Data Presented at American Pain Societys Annual Meeting
2. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
5. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
6. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
7. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
8. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
9. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
10. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
11. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... 29, 2014  United Therapeutics Corporation (NASDAQ: ... for the District of New Jersey ... case against Sandoz, Inc. regarding United Therapeutics, Remodulin ® ... ruled that U.S. Patent No. 6,765,117 is both valid ... marketing its generic product until the expiration of that ...
(Date:8/29/2014)... -- ChemImage will present a workshop focused on hyperspectral ... Science Society,s 22 nd International Symposium on ... .  Forensic Scientists will be in attendance ... can bring to examination procedures. ... Development at ChemImage, will host a workshop during ...
(Date:8/29/2014)... Columbia and MENLO PARK, Calif. ... DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar" "the Company") ... year-end financial statements.  The Company recently changed its fiscal ... an application to list its common stock on a ... DelMar,s financial statements as filed with the United ...
Breaking Medicine Technology:District Court Decision Received In Remodulin Patent Case 2ChemImage to Discuss Hyperspectral Imaging for Forensic Investigation at the ANZFSS 22nd International Symposium on the Forensic Sciences 2ChemImage to Discuss Hyperspectral Imaging for Forensic Investigation at the ANZFSS 22nd International Symposium on the Forensic Sciences 3DelMar Pharmaceuticals Fiscal 2014 Year End Results and Summary of Recent Developments 2DelMar Pharmaceuticals Fiscal 2014 Year End Results and Summary of Recent Developments 3DelMar Pharmaceuticals Fiscal 2014 Year End Results and Summary of Recent Developments 4DelMar Pharmaceuticals Fiscal 2014 Year End Results and Summary of Recent Developments 5
... CentraState Healthcare System announced today an agreement ... health information exchange (HIE) services to its physicians ... other clinicians within its broad medical community.   ... deploy its 4D HIE™, which is comprised of ...
... 5, 2011 Max Neeman announces the grant ... few Indian CROs to be certified for Information ... This updated certification of the world ... (BS 7799-2:2002) is the standard outlining requirements for ...
Cached Medicine Technology:CentraState Healthcare System Selects MobileMD for Health Information Exchange; Introduces EMR Light to Healthcare Community 2CentraState Healthcare System Selects MobileMD for Health Information Exchange; Introduces EMR Light to Healthcare Community 3Max Neeman International ISO 27001:2005 Certified for Information Security Management Systems 2
(Date:8/30/2014)... 30, 2014 Seniors Guide, the comprehensive guide ... focus on Alzheimer’s Disease, Dementia, and Memory Loss . ... public of being diagnosed with the Alzheimer’s, inspired Seniors Guide ... Be Me”. The movie, out on October 14, 2014, ... his diagnosis of the disease – which inspires a final ...
(Date:8/30/2014)... 2014 Continuing to meet the skin ... with the addition of a new doctor and office ... provided leading-edge skin care in Grand Rapids since 1980 ... “As a doctor, my passion is making sure my ... Forefront Dermatology, I’m better able to focus on my ...
(Date:8/30/2014)... Hastings and Hastings, a qualified team of ... is pleased to report having saved a client $67,100 ... many cases where Hastings and Hastings has tailored its ... greater portion of their settlement or recovery. The firm ... solution for Arizona car accident victims is achievable through ...
(Date:8/30/2014)... 30, 2014 Market Research Report ... is a professional and in-depth market survey on ... firstly reviews the basic information of Lab Oven ... report then explores global and China’s top manufacturers ... production value, and market share etc. , The ...
(Date:8/30/2014)... Bringing forth the great opportunities, ... the Labor Day discount on all SEO services. While ... complete services related to internet marketing. Their dedicated team ... others do have a deep understanding for their specialization. ... work and since the inception, they have worked with ...
Breaking Medicine News(10 mins):Health News:Alzheimer’s Disease and Dementia Focus on Retirement Website SeniorsGuideOnline.com 2Health News:Expanding Care at the Forefront of Dermatology 2Health News:Hastings and Hastings Is Pleased To Report Having Saved A Client $67,100 On A Settlement Of $610,000 2Health News:Lab Oven Industry for Global and Chinese Market Forecasts to 2019 in New Research Report Available at ReportsnReports.com 2Health News:Lab Oven Industry for Global and Chinese Market Forecasts to 2019 in New Research Report Available at ReportsnReports.com 3Health News:Lab Oven Industry for Global and Chinese Market Forecasts to 2019 in New Research Report Available at ReportsnReports.com 4Health News:Profit By Search Announces Labor Day Discount on SEO Services 2
... it plans to report third quarter 2008 financial results before the market ... ... Wire EON) October 30, 2008 -- The company also plans to ... in New York City on November 3, 2008 at 11:20 a.m. EST ...
... Election Day, researchers from Harvard School of Public Health and ... New England Journal of Medicine, find that seven ... the U.S. health care system. , The article, written by ... Analysis at the Harvard School of Public Health, Drew E. ...
... Inc.,(NYSE: RBN ) announced today that it will ... on November 10th at 11:35 a.m. (Eastern) at The,Peninsula ... Chief,Executive Officer and Christopher M. Hix, Vice President and ... the presentation,will be made available on the Company,s website ...
... BATESVILLE, Ind., Oct. 30 Hill-Rom Holdings,Inc.,s, (NYSE: ... earnings,release will be issued Monday, November 10, 2008. You ... on Tuesday, November 11,2008 at 8 a.m. EST., ... Year End Earnings Release for the quarter and year ...
... DIEGO, Oct. 30 AMN Healthcare Services,Inc. (NYSE: AHS ) ... -- Revenue of $315 million, up 5% over last ... slightly below Company guidance. -- Revenue growth primarily driven by ... largest segments, Nurse & Allied and Locum Tenens. -- EPS ...
... DATA ), a technology and services company focused ... announced that,it will host a conference call to discuss ... 4:30 p.m. ET on Thursday, November 6, 2008., ... 412-858-4600 a,few minutes before 4:30 p.m. ET. The conference ...
Cached Medicine News:Health News: Dynavax to Report Third Quarter 2008 Financial Results : -- To Present at Oppenheimer's Healthcare Conference -- 2Health News:Pre-election surveys show deep concern about state of health care 2Health News:Hill-Rom Holdings, Inc. Invites You to Join Its Fiscal 2008 Fourth Quarter and Year End Earnings Webcast 2Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 2Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 3Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 4Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 5Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 6Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 7Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 8Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 9Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 10Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 11Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 12Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 13Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 14Health News:AMN Healthcare Announces Third Quarter 2008 Results and Updates Full Year Guidance 15Health News:DATATRAK International Management to Host Conference Call on November 6, 2008 to Discuss Third Quarter and Nine Month Operating Results for 2008 2Health News:DATATRAK International Management to Host Conference Call on November 6, 2008 to Discuss Third Quarter and Nine Month Operating Results for 2008 3
Titanium. Curved shafts with 5.5 mm tying platform. Round knurled handle with dull finish. Overall length 4.3 inches....
Angled 45 degree shafts 8 mm from tip to bend with 5 mm tying platform. Serrated handle with dull finish. Overall length 3.3 inches....
Angled 45 degree shafts 8 mm from tip to bend with 4 mm tying platform. Smooth handle with dull finish. Overall length 3.2 inches....
Straight shafts with 4 mm tying platform. Wide serrated handle with dull finish. Overall length 4.3 inches....
Medicine Products: