Navigation Links
Advisory Committee Briefing Materials for CRESTOR(R) sNDA Available on US FDA Web Site
Date:12/11/2009

benefit-to-risk profile for rosuvastatin for the primary prevention of CVD in middle and older aged low-to-moderate cardiovascular disease (CVD) risk individuals with levels of LDL-C <130 mg/dL and hsCRP greater than or equal to 2 mg/L. The FDA Advisory Committee will also discuss three non-voting questions related to imbalances in gastrointestinal-related deaths and confusional state as well as the investigator-reported diabetes as observed in JUPITER.

AstraZeneca looks forward to presenting and discussing the data on December 15(th) and to continuing to work with the FDA to progress the sNDA towards the approval of an indication that supports the appropriate use of CRESTOR on the basis of this data.

In adults, CRESTOR is prescribed along with diet for lowering high cholesterol. CRESTOR is also prescribed along with diet to slow the progression of atherosclerosis (the build-up of plaque in arteries) as part of a treatment plan to lower cholesterol to goal. The approved indications are not scheduled to be part of the discussion at the upcoming meeting.

ABOUT JUPITER:

Results from the primary analysis of JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) were originally presented in November 2008 at the American Heart Association's Annual Scientific Sessions and published by the New England Journal of Medicine, evaluated the impact of rosuvastatin 20 mg on reducing CV events (combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes).

JUPITER was a long-term, randomized, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20 mg decreases the risk of myocardial infarction, stroke and other cardiovascular events in patients with LDL-C < 130 mg/dL but at i
'/>"/>

SOURCE AstraZeneca
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)
2. Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
3. Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Review of its Phase 1/2 Trial of tgAAC94 for Rheumatoid Arthritis
4. Schiffrin Barroway Topaz & Kessler, LLP and Janet Jenner & Suggs, LLC Comment on Conagra Advisory Regarding Pot Pies Linked to Salmonella Outbreak
5. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
6. FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
7. HUYA Bioscience Intl Announces World-Class Clinical Advisory Team for New Anti-Arrhythmic Compound Sourced From China
8. FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
9. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
10. UBC Forms European Advisory Board to Enhance Data Quality of CNS Trials
11. FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014  A novel wearable injector slightly larger ... painless for patients to self-inject prescription drugs in the large ... cancer, blood diseases, autoimmune deficiencies, and genetic disorders.  ... to $220B by 2018, according to analysts.   Many of these ...
(Date:1/14/2014)... HILLS, Calif. , Jan. 14, 2014 The Brandeis Medical ... Los Angeles a premier and affordable laser tattoo removal ... special. Dr. Brandeis, focus is in providing high quality cosmetic services ... all patients. " Southern California has ...
(Date:1/14/2014)... 14, 2014   NuAire , a manufacturer of ergonomically designed ... Hitachi Koki of Japan to sell ... America . NuAire will utilize its network of sales professionals ... Canada to offer assistance in application use, product benefits ...
Breaking Medicine Technology:Enable Injections Presents A New Class of Injectors for Drug Delivery at PEPTalk, Drug Delivery Partnership Meetings 2Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2NuAire announces sales and service of Hitachi Koki centrifuges in North America 2
... N.C., Oct. 31 AlphaVax, Inc.,announced today that it ... of an influenza vaccine based on its proprietary replicon ... properties of this,unique vector system as well as the ... was a placebo-controlled, randomized, double-blind trial in,healthy adults, 18-40 ...
... guide low-income,and minority cancer patients through cancer treatment, ... major obstacles that prevent them,from receiving quality care ... October 28, 2007, at the American Society for ... Angeles. Minority and low-income cancer patients continue ...
Cached Medicine Technology:AlphaVax Announces Results From Phase 1 Influenza Vaccine Clinical Trial 2Patient Navigators Help Minority, Low-Income Cancer Patients Get Life-Saving Treatments 2
(Date:7/9/2014)... researchers reveal that sudden, acute episodes of low back ... temperature, humidity, air pressure, wind direction and precipitation. Findings ... journal of the American College of Rheumatology (ACR), indicate ... with higher wind speed or wind gusts, but was ... Health Organization (WHO) nearly everyone experiences low back pain ...
(Date:7/9/2014)... A network of signals active in almost all types ... into overdrive, and may help fuel a tumour,s uncontrolled ... of Cancer Research, London, identified a molecular trigger responsible ... the cellular factory that makes the building blocks ... in the TOR signalling pathway, called SREBP, controls the ...
(Date:7/9/2014)... fecal transplantation is effective and safe for treating ... result of a study led by Colleen Kelly, M.D., ... at The Women,s Medicine Collaborative. The study and its ... in the American Journal of Gastroenterology . , ... has increased to epidemic proportions over the past decade. ...
(Date:7/9/2014)... 9, 2014 There has been a sharp increase ... Medical Center using MyChart, the online, interactive service that ... with their healthcare providers, schedule appointments, and renew prescriptions. ... actively using MyChart each year increased five-fold, ... more than 10-fold, according to a study by ...
(Date:7/9/2014)... Infectious Diseases (NIAID), part of the National Institutes ... of CRS3123, an investigational oral antibiotic intended to ... ) infection. CRS3123 (previously known as REP3123) is ... while sparing normal intestinal bacteria. , The Phase ... men and women ages 18 to 45 in ...
Breaking Medicine News(10 mins):Health News:Low back pain? Don't blame the weather 2Health News:Signal may send cancer's cellular factories into overdrive 2Health News:Women's Medicine Collaborative examines safety of fecal transplant to treat C. difficile 2Health News:MyChart use skyrocketing among cancer patients, UT Southwestern study finds 2Health News:MyChart use skyrocketing among cancer patients, UT Southwestern study finds 3Health News:NIH launches Phase I clinical trial of novel drug to treat Clostridium difficile infection 2
... and in the care of state institutions, should be ... and treatment, Health// Minister Manto Tshabalala-Msimang said. ... members, at Weskoppies psychiatric hospital, Pretoria, the minister said ... the past that mental health care users could be ...
... access journal Substance Abuse Treatment, Prevention and policy unwinds that ... the alcohol dependent patients better for a long term. ... GPs who abstain from drinking alcohol is more than the ... alone at the medical school. Also the abstinence is ...
... Post Menopausal women with early breast cancer who have ... to a more modern therapy with the drug//, Arimidex ... AstraZeneca. ,The company AstraZeneca has stated that ... women who have already received a partial course of ...
... death of 113 animals associated with the anthrax outbreak ... in Saskatchewan. Spore-forming bacteria that can spread// among animals ... anthrax. ,The Canadian Food Inspection Agency (CFIA) ... animals on farms tested positive for anthrax. However some ...
... claims to have reached, and exceeded, its medical recruitment ... the need// for an additional $5 billion for mental ... planned to employ400 more allied health professionals, 500 more ... ,According to Health Minister Stephen Robertson the ...
... their new studies have concluded that persons who live ... serious heart condition when compared to people// who live ... Melgaard Nielsen, Ph.D., and colleagues, of the Aarhus Sygehus ... on 138,000 adults between the ages of 30-69. Their ...
Cached Medicine News:Health News:Queensland Government to Meet its Medical Targets 2Health News:Significant Increase In Heart Diseases Found In Older People Living Alone 2
... generators are meeting the clinical needs ... and anesthesiologists. And, they are of ... from Medtronic.,Effective pacing with the adjustment ... for quick battery changes. Both ...
... CardioVad is a unique left ventricular assist device ... It is being used in a small group ... as part of an FDA-approved Feasibility Study. The ... the external power source for minutes or hours. ...
... Inc. has introduced the world's first minimally-invasive ... 10626 Epicardial Lead Implant Tool, which has ... States, will expand the options available to ... 5071 lead on the heart during pacemaker ...
The Schiller treadmill ergometer is designed for stress tests, sports medicine and cardiology. It is equipped and tested with the latest safety system and has been manufactured under the stringent qu...
Medicine Products: