Navigation Links
FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)
Date:2/27/2009

ult in chronic airway inflammation(4) and progressive loss of lung function, making it difficult to breathe normally.(4,6)

The FDA approval is based on two pivotal (Phase III) efficacy and safety trials, SHINE and SUN, which evaluated more than 3,600 patients ages 40 years and older with moderate to very severe COPD. (2) These studies demonstrated that patients using SYMBICORT pMDI 160/4.5 mcg had significantly greater mean improvements from baseline in pre-dose forced expiratory volume in one second (FEV1) averaged over the treatment period compared with formoterol 4.5 mcg and placebo.(2)

In addition, patients using SYMBICORT had significantly greater mean improvements from baseline in 1-hour post-dose FEV1 averaged over the treatment period compared with budesonide 160 mcg and placebo.(2) Furthermore, the median time to onset of significant bronchodilation (greater than or equal to 15% improvement in FEV1) was five minutes.(1)

SYMBICORT was generally well-tolerated over the 12-month study,(2) and the incidence of pneumonia was no different for SYMBICORT compared to placebo.(2) There was a higher incidence of potential lung infections other than pneumonia (e.g., bronchitis and viral lower respiratory tract infections) in patients receiving SYMBICORT 160/4.5 mcg than in those receiving formoterol 4.5 mcg or placebo.(2) The most common drug-related adverse events reported were nasopharyngitis (the common cold), oral candidiasis, bronchitis, sinusitis and viral upper respiratory tract infection.(2)

"Through these pivotal studies, SYMBICORT demonstrated rapid and sustained improvements in lung function and was generally well-tolerated long-term for patients with moderate to severe COPD,"(2) said lead investigator Dr. Donald Tashkin of the University of California, Los Angeles (UCLA). "Healthcare professionals and patients with severe COPD can now consider using SYMBI
'/>"/>

SOURCE AstraZeneca
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. FDA Approves Apidra(R) SoloSTAR(R) - a Prefilled Disposable Insulin Pen
2. European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI
3. Encouraging high-risk research: DFG approves funding for 2 new Reinhart Koselleck projects
4. FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout
5. FDA Approves Clinical Studies of a Novel Anti-Cancer Drug Developed by Italian Researchers
6. FDA Approves KAPIDEX(TM) (Dexlansoprazole) delayed release capsules for the Treatment of GERD
7. Bion Announces PENNVEST Board Approves $7.8 Million Financing for Kreider Farms Dairy Project
8. Monsanto Board Approves 10 Percent Dividend Increase
9. FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis C
10. MultiVu Video Feed: U.S Food and Drug Administration (Fda) Approves Latisse(TM) --
11. FDA Approves Boston Scientifics Express(R) SD Renal Stent System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... April 17, 2015  Centrillion Technologies, a ... grant from the National Human Genome Research ... Health (NIH). The grant will help fund ... development of breakthrough genomic technologies, including phased ... substrates. Centrillion has been developing this transformative ...
(Date:4/17/2015)... Reed Technology and Information Services ... management, preparation, and submission to the U.S. Food and ... new Lot Distribution Report (LDR) service for manufacturers of ... with the FDA’s new rule on electronic submission of ... the volume and timing of particular biologics introduced to ...
(Date:4/17/2015)... CIO Review ( http://www.cioreview.com ) has chosen ... Pharma and Life Science Technology Solution Providers 2015. The ... platform for life sciences companies. , The annual ... experts and members of CIO Review’s editorial board to ... been on our radar for some time now for ...
(Date:4/17/2015)... - SQI Diagnostics Inc. (TSX-V: SQD; OTCQX: SQIDF), a ... commercializes proprietary technologies and products for advanced microarray ... approval from the TSX Venture Exchange to extend ... warrants ("the Warrants") of the Company, which were ... private placement financing. Each Warrant entitles ...
Breaking Biology Technology:Reed Tech Announces FDA Lot Distribution Report (LDR) Service for Manufacturers of Biologic Products 2Reed Tech Announces FDA Lot Distribution Report (LDR) Service for Manufacturers of Biologic Products 3MMIS Chosen by CIO Review as Top 20 Most Promising Pharma and Life Science Technology Solution Providers 2015 2SQI Diagnostics to Extend Warrant Expiry 2SQI Diagnostics to Extend Warrant Expiry 3
... 2011 RiverVest Venture Partners®, a venture capital ... companies, today announced that John McKearn, Ph.D., has ... Dr. McKearn joined RiverVest as Venture Partner in ... pharmaceutical research and development as former president and ...
... 3, 2011 Cynosure, Inc. (NASDAQ: CYNO ) today ... Revenues for the first quarter of 2011 increased ... period of 2010.   Net loss for the first quarter of ... compared with a net loss of $2.8 million, or $0.22 per ...
... MAP Pharmaceuticals, Inc. (Nasdaq: MAPP ) today announced ... The net income for the first quarter ended ... loss of $14.1 million during the same period in 2010. ... was related primarily to the $34.2 million in collaboration revenue ...
Cached Biology Technology:John McKearn, Ph.D., Promoted to Managing Director of RiverVest Venture Partners 2Cynosure Reports Financial Results for the First Quarter of 2011 2Cynosure Reports Financial Results for the First Quarter of 2011 3Cynosure Reports Financial Results for the First Quarter of 2011 4Cynosure Reports Financial Results for the First Quarter of 2011 5Cynosure Reports Financial Results for the First Quarter of 2011 6MAP Pharmaceuticals Reports First Quarter of 2011 Financial Results 2MAP Pharmaceuticals Reports First Quarter of 2011 Financial Results 3MAP Pharmaceuticals Reports First Quarter of 2011 Financial Results 4MAP Pharmaceuticals Reports First Quarter of 2011 Financial Results 5
(Date:4/17/2015)... Increasing adoption in ... to drive biometric systems market in ... According to a recently released TechSci Research ... biometric systems market in Saudi Arabia ... CAGR of over 22% through 2020. The market ...
(Date:4/14/2015)...  HYPR Corp. today announced it has joined ... tm , an industry consortium transforming online authentication ... technology and collaborate to deliver open specifications for ... and private, and easier to use. ... sensitive user information and eliminates the dependency on ...
(Date:4/14/2015)... -- NXT-ID, Inc. (NASDAQ: NXTD ) ("NXT-ID" or ... growing mobile commerce market, announces that its Wocket® smart ... Design Awards under the category  ,Product Design – Technology,. ... are part of a global multi-disciplinary awards program. The ... marketplace, industry and judging panel. Winners will be announced ...
Breaking Biology News(10 mins):Saudi Arabia Biometric Systems Market to Grow at 22% Through 2020, Says TechSci Research 2Saudi Arabia Biometric Systems Market to Grow at 22% Through 2020, Says TechSci Research 3HYPR Corp. Joins the FIDO Alliance 2HYPR Corp. Joins the FIDO Alliance 3NXT-ID's Wocket Smart Wallet Nominated for 2015 New York Design Awards in 'Product Design- Technology' 2NXT-ID's Wocket Smart Wallet Nominated for 2015 New York Design Awards in 'Product Design- Technology' 3
... latest research discoveries on diabetes, obesity, endocrine-disrupting chemicals, adolescent health ... press conferences at ENDO 2013: The 95th Annual Meeting & ... Saturday, June 15 Adolescent Health ... used to help teens with conditions including eating disorders and ...
... 2013The Roy J. Carver Charitable Trust has awarded a ... at the University of Illinois at Urbana-Champaign. Under the ... Investigator Dr. Christopher Rao, the grant will be disbursed ... for a new research theme devoted to the new ...
... oceans absorb about 25 percent of the carbon dioxide ... they have taken up about half of the man-made ... seen with the naked eye, make this valuable service ... seawater, various species convert it to organic carbon and ...
Cached Biology News:Roy J. Carver Charitable Trust funds new research focus at Institute for Genomic Biology 2Fast-sinking jellyfish could boost the oceans' uptake of carbon dioxide 2Fast-sinking jellyfish could boost the oceans' uptake of carbon dioxide 3
... Gene Pulser Xcell microbial system, 100 ... used for electroporation of bacterial and ... main unit, PC module for exponential ... sterile cuvettes (5 each of 0.1 ...
... Array (MSTA) slides were designed to study protein ... multiple species. Tissue slices from three different ... can then be treated as a single histological ... situ hybridization. This format allows a ...
... is used to predict the ... sequence up to 3,200 bases, ... of primers and GC clamps ... gradient gel electrophoresis (DGGE), constant ...
... RNAi Services offer you a full ... studies. B-Bridges advanced design parameters, effective ... ensure that you obtain quality results ... Design Service utilizes their proprietary B-Algo ...
Biology Products: