Navigation Links
AstraZeneca Comments on FDA Joint Advisory Committee Meeting on Post-Marketing Safety Studies for the Use of LABAs in Asthma
Date:3/11/2010

WILMINGTON, Del., March 11 /PRNewswire-FirstCall/ -- On March 10-11, 2010, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) -- including the Pulmonary-Allergy Drugs and the Drug Safety and Risk Management Advisory Committees -- discussed the design of post-marketing safety studies for long-acting beta-agonist (LABA)-containing products in the U.S., including SYMBICORT® (budesonide/formoterol fumarate dihydrate).

(Logo:  http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO )

"As we've witnessed over the past two days, there are many challenges in designing and executing a relevant, feasible and ethical post-marketing safety study that answers FDA's question regarding LABA-containing products," said Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca.  "AstraZeneca (NYSE: AZN) is confident in the positive benefit-risk profile of SYMBICORT in asthma as demonstrated by extensive clinical data and patient experience, and supports ongoing scientific discussion to address any outstanding questions regar
'/>"/>

SOURCE AstraZeneca
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. AstraZeneca and Dako Sign Agreement to Develop Companion Diagnostics for Cancer Treatments
2. AstraZeneca Offers Online Enrollment and Additional Improvements to Patient Assistance Program
3. Novexel to be Acquired by AstraZeneca
4. AstraZeneca Medicare Part D Patient Assistance Program No Longer Requires Co-Pays
5. U.S. Court of Appeals Upholds AstraZeneca AWP Settlement
6. Emerging Agents from Theravance/Astellas, Johnson & Johnson/Basilea and Forest/Astrazeneca/Takeda Will Drive Modest Growth in the MRSA Drug Market Through 2018
7. Dr. Steven M. Paul to Retire from Lilly as Executive Vice President, Science and Technology, President, Lilly Research Laboratories; Dr. Jan M. Lundberg, Executive Vice President, Head of Global Discovery Research, AstraZeneca, Named his Successor
8. Jubilant Enters Research Collaboration With AstraZeneca
9. AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product
10. AstraZenecas Partner, MAP Pharmaceuticals, Announces Phase 3 Study of Unit Dose Budesonide in Children with Asthma Did Not Meet Primary Endpoints
11. AstraZeneca Responds to FDA Joint Advisory Committees Recommendation on SYMBICORT(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/2/2015)... DUBLIN , June 02, 2015 Research ... of the "Europe Fluoroscopy Market - Growth, Trends ... offering. The European market for Fluoroscopy is ... to 2020 Fluoroscopy is used to view ... catheter through blood vessels, bile ducts or the urinary ...
(Date:6/2/2015)... June 02, 2015 Research and Markets ( http://www.researchandmarkets.com/research/zkkg9q/blood_processing ... Supplies and Equipment - Global Strategic Business Report" report ... analytics for the US, Canada , ... Asia-Pacific , Latin America , ... for the period 2014 through 2020. Also, a seven-year historic ...
(Date:6/2/2015)... FORT WORTH, Texas , June 2, 2015 ... simulation market report defines and segments the concerned ... market was valued at $261.8 million in 2014, ... 2019, at a CAGR of 19.3% from 2014 ... of North America Mannequin-Based Simulation Market for an ...
Breaking Medicine Technology:European Fluoroscopy Market Report 2014-2019 - Growth, Trends And Forecasts 2Blood Processing Supplies and Equipment Market - Global Strategic Business Report 2015-2020 2Blood Processing Supplies and Equipment Market - Global Strategic Business Report 2015-2020 3North America Mannequin-Based Simulation Market is Expected to Reach $632.5 Million by 2019, at a CAGR of 19.3% From 2014 to 2019 2North America Mannequin-Based Simulation Market is Expected to Reach $632.5 Million by 2019, at a CAGR of 19.3% From 2014 to 2019 3
... Cayenne Medical, Inc., a private sports medicine ... 50,000 implant milestone.  Specializing in the soft tissue ... unmet clinical needs in knee ligament reconstruction and ... Repair System and iFix™ System.  The announcement was ...
... YORK, Nov. 18, 2010 Reportlinker.com announces that ... its catalogue: Global Freeze Drying ... This report analyzes the worldwide markets ... the following Product Segments: Laboratory Freeze Drying Equipment, ...
Cached Medicine Technology:Cayenne Medical, Inc. Reaches 50,000 Implant Milestone 2Cayenne Medical, Inc. Reaches 50,000 Implant Milestone 3Reportlinker Adds Global Freeze Drying Equipment Industry 2Reportlinker Adds Global Freeze Drying Equipment Industry 3Reportlinker Adds Global Freeze Drying Equipment Industry 4Reportlinker Adds Global Freeze Drying Equipment Industry 5Reportlinker Adds Global Freeze Drying Equipment Industry 6Reportlinker Adds Global Freeze Drying Equipment Industry 7Reportlinker Adds Global Freeze Drying Equipment Industry 8Reportlinker Adds Global Freeze Drying Equipment Industry 9Reportlinker Adds Global Freeze Drying Equipment Industry 10Reportlinker Adds Global Freeze Drying Equipment Industry 11Reportlinker Adds Global Freeze Drying Equipment Industry 12Reportlinker Adds Global Freeze Drying Equipment Industry 13Reportlinker Adds Global Freeze Drying Equipment Industry 14Reportlinker Adds Global Freeze Drying Equipment Industry 15
(Date:6/2/2015)... 02, 2015 On Wednesday, May 27, 2015, ... to a top speed of 207.9 mph. In the ... to break the 200 mph mark. Jay Leno was ... upcoming episode of Jay Leno’s Garage, which will air on ... the 8.5 mile high speed oval at the Continental Tire ...
(Date:6/2/2015)... WI (PRWEB) June 02, 2015 The ... announce Lauren Potter from the hit show Glee as ... Syndrome Awareness Walk in Pleasant Prairie, WI. The event ... for families in Racine, Kenosha, and Walworth counties. ... have Lauren join us for this important event," says ...
(Date:6/2/2015)... N.Y. (PRWEB) June 02, 2015 The ... to computer generated imagery overlaid on the real world. ... but Vein Visualization, which displays a map of the ... a steady growth in adoption. , AccuVein, the leader ... year over year growth rate and such widespread adoption ...
(Date:6/2/2015)... Gujarat, India (PRWEB) June 02, 2015 ... finalist in the 2015 Microsoft Worldwide Small and Midsized ... global field of top Microsoft partners for demonstrating excellence ... Microsoft technology. , “This comes as no surprise ... are recognized third year consecutively at worldwide level by ...
(Date:6/2/2015)... Did you wish Ryder Weise a happy sixth birthday today? ... asking for presents, but instead a donation to the ... DC Walk. , Ryder was diagnosed with HHT in December ... to sudden and extreme bleeding throughout the body. Though ... old in the form of daily nosebleeds, fatigue and shortness ...
Breaking Medicine News(10 mins):Health News:774 HP Hennessey Mustang Tested to 207.9 mph 2Health News:Glee star Lauren Potter helps Down Syndrome Association of WI raise awareness, support 2Health News:Vein Visualization Emerges as Premier Augmented Reality Application 2Health News:Bitscape Infotech recognized as finalist for 2015 Microsoft Worldwide small & midsized cloud solutions award. 2Health News:Bitscape Infotech recognized as finalist for 2015 Microsoft Worldwide small & midsized cloud solutions award. 3Health News:Six-Year-Old Walks to Bring Awareness to Genetic Disease 2
... rapidly, the University of Missouri has made a commitment to ... community and across the country. MU was one of ... Difficult Dialogues Initiative (DDI) in 2005, and one of only ... additional $100,000 grant in 2008. DDI activities focus on teaching ...
... treated with the anticoagulant fondaparinux who underwent a coronary ... dose of the anticoagulant heparin during the procedure did ... vascular access site complications, according to a study that ... JAMA . The study is being released early online ...
... of acute myocardial infarction in Italy sharply increased, particularly ... according to a comprehensive study funded by the Human ... research and health education in Spoleto, Italy. The results ... "The study suggests that more information on measures to ...
... By Alan Mozes HealthDay Reporter , MONDAY, Aug. ... may raise the risk for breast cancer recurrence in some ... former breast cancer patients who are postmenopausal or overweight or ... to four drinks per week) was not linked to increased ...
... Reporter , MONDAY, Aug. 30 (HealthDay News) -- Smoking ... with nerve pain stemming from injuries or surgical complications, ... pain were taught to take a single inhalation of ... a day, for five days. The cannabis contained one ...
... August 2010 - The notion that cutting or burning ... to understand for most people, but it is an ... Individuals with borderline personality disorder experience intense ... skills. This group of people also displays high prevalence ...
Cached Medicine News:Health News:Difficult Dialogues Initiative promotes diversity at MU, around country 2Health News:Lower-dose heparin use during coronary procedure does not appear to reduce risk of major bleeding 2Health News:Lower-dose heparin use during coronary procedure does not appear to reduce risk of major bleeding 3Health News:Heart attacks jump in young Italian women 2Health News:Moderate Drinking May Boost Risk of Breast Cancer's Return 2Health News:Moderate Drinking May Boost Risk of Breast Cancer's Return 3Health News:Smoked Marijuana May Ease Chronic Nerve Pain 2Health News:Smoked Marijuana May Ease Chronic Nerve Pain 3Health News:Hurts so good -- neural clues to the calming effects of self-harm 2
Grab one and go, One of the smallest handheld oximeters available, Datex-Ohmeda s TuffSat is the ideal spot-check solution for hospital, home care, transport, and EMS. TuffSat comes fully loaded wi...
The Stat Profile pHOx CO-Oximeter is intended for use in those situations where a more comprehensive profile beyond the measured hematocrit, hemoglobin, and SO2% offered by the Stat Profile pHOx ...
Smith & Nephew's CDS System is developed exclusively for discography., Developed exclusively for discography, it is the first system designed to measure true disc pressure and record real-time proce...
Maxi-Therm® hyper-hypothermia water blankets from Cincinnati Sub-Zero are designed for single-patient use. These blankets are easy to clean, stain resistant and ideal for isolation cases....
Medicine Products: