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:7/9/2014)... Researchers have found that fecal transplantation is effective ... immunocompromised patients. This is the result of a study ... Center for Women,s Gastrointestinal Medicine at The Women,s Medicine ... online in advance of print in the American ... or C. diff , has increased to epidemic ...
(Date:7/9/2014)... are personal and subjective, the human brain turns ... emotions across different senses, situations and even people, ... Adam Anderson. , "We discovered that fine-grained patterns ... area of the brain associated with emotional processing, ... individual,s subjective feeling," says Anderson, associate professor of ...
(Date:7/9/2014)... 8, 2014) Researchers from Montefiore Medical Center ... of Yeshiva University will present new findings at ... 12 July 17 in Copenhagen, Denmark. Data from ... prompt transition from cognitive normality to mild cognitive impairment ... Einstein Aging Study , established in 1980 to examine ...
(Date:7/9/2014)... smell of flatulence and have a reputation for being highly ... sulfide is now being being found to offer potential health ... heart attacks and dementia. A new compound (AP39), designed and ... to future therapies, by targeting delivery of very small amounts ... cells. , Scientists in Exeter have already found that ...
(Date:7/9/2014)... conducted by researchers at Tufts University School of Dental ... and developmental disabilities, the likelihood of having cavities decreased ... The findings, published in the July/August issue of ... designed to address the oral health of individuals in ... records of 107 patients at one of the eight ...
Breaking Medicine News(10 mins):Health News:Women's Medicine Collaborative examines safety of fecal transplant to treat C. difficile 2Health News:Study cracks how the brain processes emotions 2Health News:Investigators from Montefiore and Einstein to present data at 2014 Alzheimer's Association International Conference 2Health News:Investigators from Montefiore and Einstein to present data at 2014 Alzheimer's Association International Conference 3Health News:Rotten egg gas holds key to healthcare therapies 2Health News:Adults with special needs see gains, challenges with long term oral care 2Health News:Adults with special needs see gains, challenges with long term oral care 3
... , , , WASHINGTON, ... Produce Safety Project: , , We commend the FDA ... The proposed guidance documents put out for comment today address three ... these documents quickly. We also look forward to the agency,s next ...
... ... in Webinar Series on "How Generation and Gender Impact Physician Engagement" , ... Charlotte, N.C. (Vocus) July 31, 2009 -- ... in Physician Engagement." The free hour-long ,webinar will be broadcast on Wednesday, August ...
... SHENZHEN, China, July 31 /PRNewswire-FirstCall/ ... announced today that its,registration dossier for MEVAC-DTaP (Diphtheria, Tetanus ... consideration,of the experts in Thai FDA. The sample analysis ... , Mr. Terry Yuan CEO ...
... , COLUMBIA, S.C., July 31 Amid rising ... benefits of including international medical travel coverage in their employee ... possible risks associated with offering such options. , , ... Global Healthcare Inc. today announced an agreement with an insurer ...
... skills, researchers say , FRIDAY, July 31 (HealthDay News) ... should learn cardiopulmonary resuscitation (CPR), Austrian researchers say. , In ... life-support training, 86 percent of the children performed CPR correctly ... to the report published online in the journal Critical ...
... , , , ... Language Line Services , the leading provider of ... evening, July 23rd at a Recognition and Awards Banquet at Bellevue University, ... Wray, President of the Nebraska Association for Translators & Interpreters (NATI), said, ...
Cached Medicine News:Health News:Webinar on "Physician Engagement - Diagnosing Generational Differences" Presented by Morehead Associates 2Health News:Webinar on "Physician Engagement - Diagnosing Generational Differences" Presented by Morehead Associates 3Health News:Hard to Treat Diseases, Inc. (HTDS) Thai Registration Dossier 2Health News:Hard to Treat Diseases, Inc. (HTDS) Thai Registration Dossier 3Health News:New Policies Protect Employers, Workers Who Choose Global Health Care 2Health News:Even 9-Year-Olds Can Learn CPR 2Health News:Language Line Services Honored by Nebraska Association for Translators & Interpreters (NATI) 2Health News:Language Line Services Honored by Nebraska Association for Translators & Interpreters (NATI) 3
(Date:1/15/2014)... GENEVA, Ill. , Jan. 15, 2014 The ... a Medical Fitness Center by the Medical Fitness Association, ... centers to achieve their full potential. The Cadence Fitness ... in the western suburbs and second in the Chicagoland ...
(Date:1/15/2014)... 2014  Valeant Pharmaceuticals International, Inc. (NYSE: VRX ... period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 ... by its indirect wholly-owned subsidiary, Sapphire Subsidiary Corp. ("Purchaser"), ... of Solta Medical, Inc. (NASDAQ: SLTM ) ...
(Date:1/15/2014)... FRANKLIN, Ohio , Jan. 15, 2014  A novel wearable ... it easy and painless for patients to self-inject prescription drugs ... of disorders, including cancer, blood diseases, autoimmune deficiencies, and genetic ... expected to grow to $220B by 2018, according to analysts.   ...
Breaking Medicine Technology:Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3Enable Injections Presents A New Class of Injectors for Drug Delivery at PEPTalk, Drug Delivery Partnership Meetings 2
... , NEWPORT BEACH, Calif., July ... from a clinical study showing patient-specific cancer vaccines derived from ... and resulted in impressive long-term survival rates in patients with ... , , The study entitled ...
... , PHILADELPHIA, July 28 Shire ... biopharmaceutical company, announces,that it has received a Complete Response letter ... Administration (FDA).,This decision comes following labeling discussions with the FDA ... PDUFA date. , The FDA did ...
Cached Medicine Technology:Study Shows Cancer Vaccines Led to Long-Term Survival for Patients with Metastatic Melanoma and to Long Periods of Disease Control After Completion of Therapy 2Study Shows Cancer Vaccines Led to Long-Term Survival for Patients with Metastatic Melanoma and to Long Periods of Disease Control After Completion of Therapy 3FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents 2FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents 3FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents 4FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents 5FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents 6
When You Need Optimal Patient Comfort with Minimal Weight at a Nonunion Site...Demand The OrthoPak Noninvasive Bone Growth Stimulator., ,Most Appropriate for the Proximal Femur, Metatarsal/Tarsal...
... Providing the surgical versatility you demand when ... new EBI OsteoGen-D offers 40 microamperes of ... each with 20 microamperes. Available in both ... superior flexibility with any of your bone ...
... cataract surgery following refractive surgery grows larger ... for surgeons, as calculating IOL power for ... power following RK, ALK, PRK and LASIK ... or topography. For example, keratometry and simulated ...
... to offer one of the ... at only 188 grams! The ... superior flow rate with effortless ... The complementing electrodes provide powerful ...
Medicine Products: