Navigation Links
AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication
Date:4/30/2008

or the average post-dose FEV1 compared with formoterol

4.5.(3)

SUN Study Results

-- 12-month randomized, double-blind, parallel-group, multi-center trial

of patients (N=1,964) with moderate to very severe COPD.(2)

-- SYMBICORT 160/4.5 mcg two puffs twice a day (320/9 mcg) met the

pre-specified co-primary endpoints.(2)

-- SYMBICORT demonstrated a statistically significantly greater increase

from baseline in pre-dose FEV1 and 1-hour post-dose FEV1 compared with

formoterol and placebo.(2)

-- Results showed an overall maintenance effect over the 12-month

treatment period in patients with moderate to very severe COPD.(2)

"SYMBICORT is a combination maintenance treatment for patients with asthma that works rapidly to help improve lung function by reducing inflammation in the lining of the lung, (4),(8)" said Howard Hutchison, Chief Medical Officer, AstraZeneca. "We are confident in the data from the SHINE and SUN trials that support our submission, and we look forward to discussions with the FDA about this potential expanded indication."

About COPD

More than 12 million people in the United States suffer from COPD, and it is the fourth leading cause of death in the nation.(1) Some estimates also suggest that 12 million more people have COPD but are undiagnosed.(1) COPD is a term referring to two serious lung diseases -- emphysema and chronic bronchitis -- that cause a person's airways to become inflamed over time, making it difficult to breathe normally.(1) Common symptoms include shortness of breath, chronic cough, wheezing and excess mucus.(1) For patients with moderate to very severe COPD, to reduce exacerbations and improve lung function and health status, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends the use of combination treatments with an inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), in addition to other tr
'/>"/>

SOURCE AstraZeneca
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
2. AstraZeneca Completes Enrollment in First Phase III Study of the Investigational Drug Vandetanib (ZACTIMA)(R) in Non-Small Cell Lung Cancer
3. New Analysis of METEOR Study Demonstrate Effects of AstraZenecas CRESTOR(R) (Rosuvastatin Calcium) on Atherosclerosis in Patients With Two or More Risk Factors for Cardiovascular Disease
4. Abbott and AstraZeneca Announce Selection of Next-Generation Fenofibrate ABT-335 and CRESTOR(R) Fixed-Dose Combination
5. Cardica Reports Positive Top-Line Results and Submits 510(k) for PAS-Port(R) Proximal Anastomosis System in Cardiac Bypass Surgery
6. CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
7. Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for XYOTAX(TM)
8. Gen-Probe Submits U.S. Regulatory Application for Additional Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
9. Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R) in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)
10. Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
11. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)... Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC ... and audio webcast to discuss financial results for the second ... July 31, 2014 at 4:30 p.m. ET. ... July 31, 2014 Time: 4:30 PM ET Listen via Internet: ... A webcast replay will be available on the ...
(Date:7/28/2014)... SAN FRANCISCO , July 28, 2014 /PRNewswire/ ... that it has received the Get With The ... quality improvement measures outlined by the American Heart ... patients. Stroke is the number four cause of ... in the United States , ...
(Date:7/28/2014)... Calif., July 28, 2014 Anthera Pharmaceuticals, Inc. (NASDAQ: ... update for the second quarter ended June 30, 2014. ... 30, 2014 was $7.3 million, compared to $8.3 million for ... is a direct result of a decrease in interest expense ... the six months ended June 30, 2014 was $15.2 million, ...
Breaking Medicine Technology:Pharmacyclics Announces Date of Conference call to discuss Financial Results for Second Quarter of 2014 2Dignity Health St. Mary's Medical Center Honored with Quality Achievement Award for Stroke Care 2Dignity Health St. Mary's Medical Center Honored with Quality Achievement Award for Stroke Care 3Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 2Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 3Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 4Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 5Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 6Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 7
... Mass., Aug. 26, 2011 - Vention Medical, ... announced today its acquisition of ANSAmed, Ireland,s ... including multilayer, co-extrusion and multi-lumen extrusion capabilities, ... The acquisition of ANSAmed will ...
... Md., Aug. 26, 2011 The FDA reminds consumers ... safety of their food and medical supplies for themselves ... hurricane-related rain, possible flooding and power outages. ... also reminds consumers that it is important to have ...
Cached Medicine Technology:Vention Medical Acquires ANSAmed 2FDA Hurricane Preparedness Checklist 2FDA Hurricane Preparedness Checklist 3FDA Hurricane Preparedness Checklist 4
(Date:7/28/2014)... Two beneficial variants of a gene controlling red blood ... human populations across the globe, according to a new ... studied the genomes of world populations to look for ... which stimulate fetal haemoglobin production into adulthood. Fetal haemoglobin ... patients with inherited blood disorders who are able to ...
(Date:7/28/2014)... VA (PRWEB) July 29, 2014 A ... the Social Security disability trust fund by reallocating payroll ... a new poll by The Senior Citizens League ... polled said shifting revenues from the Social Security retirement ... way to fix the disability program’s financing. “TSCL believes ...
(Date:7/28/2014)... NAPW honors Pamela A. ... as a 2014 Professional Woman of the Year. Ms. ... in community health. As the largest, most-recognized networking organization ... and profession, the National Association of Professional Women (NAPW) ... members and nearly 300 Local Chapters. , In her ...
(Date:7/28/2014)... have long known that they monopolize large amounts of ... cells are also characterized by a series of features ... ordered set. Researchers are calling this behavior "mesenchymal," and ... Meylan,s research team was able to demonstrate that the ... result from the same mechanism, at least in ...
(Date:7/28/2014)... (PRWEB) July 28, 2014 Evolve Medical Clinics ... 2014, offering its members virtual visits and dramatic operational changes ... , Some estimates state that as many as 70% of ... “Imagine not having to leave your office or home for ... blood pressure or cholesterol,” CEO and Founder Michael R. Freedman, ...
Breaking Medicine News(10 mins):Health News:Study tracks worldwide spread of beneficial blood cell gene variant 2Health News:Study tracks worldwide spread of beneficial blood cell gene variant 3Health News:The Senior Citizens League Finds No Support Among Seniors for Likely Disability Trust Fund Fix 2Health News:The Senior Citizens League Finds No Support Among Seniors for Likely Disability Trust Fund Fix 3Health News:National Association of Professional Women Announces Pamela A. Schulters, Head Nurse at Kings County Hospital Center, a 2014 Professional Woman of the Year 2Health News:Cancer: Tumors absorb sugar for mobility 2Health News:Evolve Medical Clinics to Open First Next Generation Primary and Urgent Care Facility 2Health News:Evolve Medical Clinics to Open First Next Generation Primary and Urgent Care Facility 3Health News:Evolve Medical Clinics to Open First Next Generation Primary and Urgent Care Facility 4
... a precarious time, as about 15 percent of women ... risk increases when pregnant women undergo surgery, which is ... instituted a same-day pregnancy testing protocol. A study published ... shows that this protocol is effective in identifying ...
... Will Expand Product Line and International ... ... PSS Systems, the leader,in legal holds and retention management solutions, announced ... existing,investors, including Lightspeed Venture Partners, Azure Capital, Granite,Ventures, and Cipio Partners, ...
... higher rate of impairment among diabetics , , MONDAY, June ... common, under-recognized complication of diabetes, suggests a U.S. study. ... common in people with diabetes than people without the ... to be caused by other factors such as exposure ...
... emotional and,energetic performances, Garth Brooks, Jon McLaughlin, and ... Foundation, a world leader in,promoting hearing health awareness, ... World May Hear" Awards Gala, held Saturday, June ... money raised at the Gala, the Starkey,Hearing Foundation ...
... Metropolitan Health Plan (MHP(R)),the HMO of Hennepin County, ... Chief Financial Officer and David R. Johnson,Executive Director., ... County for over 35,years. During his tenure at MHP, ... Medical Assistance, to a plan that offers 10 government,sponsored ...
... - Two years ago researchers at the University of ... TDP-43 accumulated in the motor areas of the brains ... Gehrig,s disease. Now, the same group has shown that ... neurological effects than previously appreciated and treatments need to ...
Cached Medicine News:Health News:Same-day pregnancy test provides valuable guidance to pre-surgery patients 2Health News:PSS Systems Secures $18 Million in Financing 2Health News:PSS Systems Secures $18 Million in Financing 3Health News:PSS Systems Secures $18 Million in Financing 4Health News:Diabetes Might Help Spur Hearing Loss 2Health News:Garth Brooks, Jon McLaughlin, and Pat Benatar and Neil Giraldo Raise Their Voices to Help Starkey Hearing Foundation Raise More Than $5 Million at Annual Fundraiser 2Health News:Metropolitan Health Plan Announces Senior Management Appointments 2Health News:Lou Gehrig's protein found throughout brain, suggesting effects beyond motor neurons 2
Abiomed introduces its new intra-aortic balloon (IAB); an easy-to-insert, minimally invasive technology designed to enhance blood flow to the heart and other organs for patients with diminished heart...
... Tip Guidewire has a flexible, radiopaque ... tip. The longitudinal distal/proximal movement of ... proximal end of the guidewire, deflects ... Guidewire length, diameter, and distal tip ...
The 3-chip MediLive Trio Eye video camera is built to adapt to changing conditions during ophthalmic surgery with features designed for workflow optimization and maximum image quality....
... GPA software accurately differentiates clinically significant ... random variability, providing an advanced, proven ... for your patients. , ,The software ... clinical trial, in which the actual ...
Medicine Products: