Navigation Links
GlaxoSmithKline Statement on FDA Advisory Committee Vote on Use of Asthma Medicines Containing Long-Acting Beta-Agonists
Date:12/11/2008

WASHINGTON, Dec. 11 /PRNewswire-FirstCall/ -- The following is GlaxoSmithKline's (NYSE: GSK) statement regarding recommendations of a combined Advisory Committee to the FDA on the use of asthma medicines containing long-acting beta agonists, including GSK's Serevent(R) (salmeterol) and Advair(R) (salmeterol/fluticasone proprionate).

"We welcome the committee's endorsement of Advair as a safe and effective treatment for asthma in adults and children," said Dr. Ellen Strahlman, Chief Medical Officer for GSK. "We believe this recommendation is consistent with national treatment guidelines -- based on evidence and developed by experts -- that support the combination of a LABA and ICS as a preferred treatment for children and adults with persistent asthma. We will continue to work with physicians to encourage broader understanding of national guidelines for appropriate use."

"Serevent, when used with an ICS, is an important treatment option for some patients as outlined in national guidelines. We are confident that our proposed new labeling, medication guide and risk management plan would help physicians safely manage the appropriate use of Serevent in conjunction with an ICS," Dr. Strahlman said. "We are concerned that -- if the FDA adopts the panel's recommendation on Serevent -- it is possible that Serevent would be severely restricted and deny patients needed treatment for optimal care of their asthma."

GSK is committed to continuing discussions with the Agency as it determines next steps following the Advisory Committee meeting.

GSK conducted an analysis of more than 200 clinical studies that included more than 100,000 patients, presenting the following information to the committees:

-- The clinical and observational data presented by GSK demonstrated better overall asthma contr
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. GlaxoSmithKline and The Carter Center Reaffirm Commitment to Global Public Health with Expansion of LF Program
2. GlaxoSmithKline to Acquire the Leading Dry Mouth Brand, Biotene
3. AUDIO from Medialink and GlaxoSmithKline: Give Kids A Boost For Their Health!
4. GlaxoSmithKline Acquires Sirtris Pharmaceuticals, Inc., a World Leader in Sirtuin Research and Development
5. Amira Pharmaceuticals Achieves Milestones in FLAP Inhibitor Program With GlaxoSmithKline
6. Emerging Combination Therapies, Including Drugs from Novartis/Schering-Plough and GlaxoSmithKline/Theravance Will Drive the COPD Drug Market to More Than $11 Billion in 2017
7. Video: GlaxoSmithKline Consumer Healthcare Offers Free Nicotine Lozenges for All Certified Pilots and Air Traffic Controllers to Help Them Safely Quit Smoking
8. GlaxoSmithKline Announces $500,000 in Fellowships at Stanford Graduate School of Business
9. IADR and GlaxoSmithKline Consumer Healthcare announce winners
10. A Statement from GlaxoSmithKline Consumer Healthcare on 2008 Update to the U.S. Public Health Service Guideline on Treating Tobacco Use and Dependence
11. Concern From Doctors Regarding the Cardiovascular Safety of GlaxoSmithKlines Avandia Increases Nine-Fold Following Publication of Meta-Analysis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/21/2015)... 2015 The report “Sinusitis ... analysis on the therapeutic development for Sinusitis. ... new targets and MOAs to produce first-in-class ... is available @ http://www.rnrmarketresearch.com/sinusitis-pipeline-review-h1-2015-market-report.html . ... involved in the therapeutic development for Sinusitis ...
(Date:4/21/2015)... April 21, 2015 Wireless Analytics, ... has been recognized by the Boston Business Journal as ... ranking was announced at a recent event celebrating the ... of the fastest-growing private companies in Massachusetts. , Wireless ... the state that recorded the fastest revenue growth from ...
(Date:4/21/2015)... April 21, 2015 QuickMedical, a ... and supplies, now represents Schiller America's ... ECGs, Stress Tests, and Vital Signs Monitors, among ... Switzerland, is a global leader in the development ... are developed in close cooperation with the world's ...
(Date:4/21/2015)... San Diego, CA (PRWEB) April 21, 2015 ... Deconstructed PACS® strategy , Visage Imaging ... Ltd. (ASX: PME), has signed a seven-year contract ... health system in Northern Florida. The deal furthers ... the university/academic hospital space, a key area of the ...
(Date:4/21/2015)... Baltimore, Maryland (PRWEB) April 21, 2015 ... air, according to the U.S. Environmental Protection Agency (EPA). ... UV rays and cigarette smoke increase the level of ... help the body eliminate these harmful toxins is to ... superfood, broccoli boasts the highest level of glucoraphanin – ...
Breaking Medicine News(10 mins):Health News:Sinusitis Therapeutic Development and Pipeline Market Review H1 2015 Available at RnRMarketResearch.com 2Health News:Sinusitis Therapeutic Development and Pipeline Market Review H1 2015 Available at RnRMarketResearch.com 3Health News:Wireless Analytics Ranked as 25th Fastest Growing Private Company in Massachusetts 2Health News:QuickMedical Launches New Product Line: Schiller America 2Health News:QuickMedical Launches New Product Line: Schiller America 3Health News:Visage Imaging Signs University of Florida Health 2Health News:Visage Imaging Signs University of Florida Health 3Health News:Visage Imaging Signs University of Florida Health 4Health News:New Survey Shows Americans Are Cooking the Health Out of Broccoli 2Health News:New Survey Shows Americans Are Cooking the Health Out of Broccoli 3
... governments, including California as well as others in Canada ... taxpayer dollars into major motion pictures that depict smoking ... year, a University of California, San Francisco (UCSF) researcher ... PLoS Medicine , those subsidies, along with government ...
... Aug. 23 (HealthDay News) -- Researchers say boys are ... that males have been reaching sexual maturity about 2.5 ... "The reason for earlier maturity for ... disease environments are getting more favorable for it," demographer ...
... By Amanda Gardner HealthDay Reporter , ... are hospitalized fail to receive their regular medications for ... restart them when they,re discharged, researchers say. Patients ... less likely to resume their regular medication schedule after ...
... Aug. 23 (HealthDay News) -- Certain types of mental illnesses ... indicates. Men are more likely to be diagnosed with ... to develop anxiety or depression, according to the researchers. ... efforts, said the study authors, who analyzed data collected in ...
... of Nottingham are to investigate whether the therapeutic effects ... their feelings of anger, anxiety and depression. Academics ... Contemporary art gallery and local artists for the innovative ... clay could offer to young people struggling with mental ...
... (HealthDay News) -- The amount of fighting and arguing in ... a new study suggests. Ohio State University researchers looked ... 1980 to 2000. Based on how often participants said they ... middle- and high-conflict marriages. There was little change in ...
Cached Medicine News:Health News:Taxpayer film subsidies promote youth smoking 2Health News:Boys Mature Sexually Earlier Than Ever Before: Study 2Health News:Mainstay Meds Often Cut Off Accidentally After Hospital Stay 2Health News:Mainstay Meds Often Cut Off Accidentally After Hospital Stay 3Health News:Mental Illness Affects Women, Men Differently, Study Finds 2Health News:Modelling emotions: A potential new therapy for disturbed teenagers 2Health News:Modelling emotions: A potential new therapy for disturbed teenagers 3Health News:Couples Who Don't Fight Much Aren't Likely to Start 2
(Date:4/21/2015)... 2015 Global cap & closure ... for caps and closures will exceed $55 billion in 2019. ... trillion annually. Beverages will continue to account for well over ... number of smaller markets are expected to register faster growth. ... the most developed markets -- the US, Western ...
(Date:4/21/2015)... Fla. , April 21, 2015  A new, ... the First Coast that promises to revolutionize the way ... fellowship-trained at the world-renowned Montsouris Institute in ... guided prostate biopsy in the North Florida ... this innovative technology in prostate cancer diagnosis and management ...
(Date:4/21/2015)... SARASOTA, Fla. , April 21, 2015   ... a drug development company focused on the treatment of ... a key independent appointment to the Company,s Board of ... Chundru Samuel as a new director. ... CEO of Rock Creek Pharmaceuticals, said, "Dr. Samuel,s experience ...
Breaking Medicine Technology:World Caps & Closures Market 2World Caps & Closures Market 3Kasraeian Urology Unveils Jacksonville's First UroNav Advanced Prostate Cancer Detection Technology 2Kasraeian Urology Unveils Jacksonville's First UroNav Advanced Prostate Cancer Detection Technology 3Rock Creek Pharmaceuticals Appoints New Director and Provides Notice of Settlement of Derivative Litigation 2Rock Creek Pharmaceuticals Appoints New Director and Provides Notice of Settlement of Derivative Litigation 3Rock Creek Pharmaceuticals Appoints New Director and Provides Notice of Settlement of Derivative Litigation 4Rock Creek Pharmaceuticals Appoints New Director and Provides Notice of Settlement of Derivative Litigation 5Rock Creek Pharmaceuticals Appoints New Director and Provides Notice of Settlement of Derivative Litigation 6Rock Creek Pharmaceuticals Appoints New Director and Provides Notice of Settlement of Derivative Litigation 7
... Combination gives you the freedom ... enhanced by distributing 70% of ... hips leaving only 30% of ... shoulders. Freedom of movement enhanced ...
A simple, one-piece design eliminates seams that irritate and also extend the life of the collar. Comes with extra long Velcro closure to fit all. Also available with trim. One size fits all. Availab...
The maternity apron is a very critical protection device for the patient and the fetus....
... Special Protective Apron is made to ... a sterile gown. Uniquely it can ... field. Reaching through the back of ... released, and the protective apron will ...
Medicine Products: