GSK receives decision from FDA on Advair 500/50 for COPD

COPD :: GSK receives decision from FDA on Advair 500/50 for COPD

GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the supplemental drug application for the 500/50 strength of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in the treatment of patients with chronic obstructive pulmonary disease (COPD).

The FDA questioned how Advair 500/50 compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations. GSK will be meeting with FDA to discuss this request in more detail and determine next steps, including discussion of data GSK has recently generated on the reduction of exacerbations with the Advair 250/50 strength.

?We are very surprised and disappointed by this FDA decision particularly given the outcome of the FDA advisory committee meeting earlier this year,? said Katharine Knobil, M.D., Vice-President of Respiratory Clinical Development for COPD at GSK. ?The advisory committee voted unanimously that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations. We believe in the strength of the data; this application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years. We are committed to working with the FDA to address any questions they have and to pursue a way forward.?




(COPD :: GSK receives decision from FDA on Advair 500/50 for COPD published at SpiritIndia on Wednesday, August 8, 2007)

COPD

Search more information on COPD, COPD books

Recently posted related articles on COPD :

1. COPD :: COPD rates, higher than expected in China, will continue to grow
2. COPD :: Poor indoor air quality means poorer health for patients with COPD
3. COPD :: Ambulatory oxygen rarely a benefit in COPD patients without resting hypoxemia
4. COPD :: Study says COPD testing is not measuring up
5. COPD :: GSK receives decision from FDA on Advair 500/50 for COPD
6. COPD :: Sex differences found in COPD
7. COPD :: COPD patients taking inhaled steroids are at greater risk for severe pneumonia
8. Psychiatry :: Psychiatric disorders prevalent among patients with COPD
9. Smoking :: Some smokers have genetic predisposition to develop COPD
10. COPD :: Premature vascular and bone changes occur in COPD patients

Most related articles:

- COPD :: GSK receives decision from FDA on Advair 500/50 for COPD
- COPD :: Short of Breath? It May Be COPD - 15.7
- Asthma :: Current Issues in Asthma and Chronic Obstructive Pulmonary Disease (COPD) - 15.6
- COPD :: Increasing awareness, early diagnosis and treatment for COPD - 15.1
- Lung Cancer :: Smokers with wrinkles at higher risk of lung cancer - 14.7
- HIV :: HIV infection linked to chronic lung disease - 14.5
- COPD :: Copd patients with acid reflux twice as likely to experience exacerbations - 14.3
- Psychiatry :: Psychiatric disorders prevalent among patients with COPD - 13.9
- COPD :: Drug treatment slows decline in lung function in COPD patients, TORCH study finds - 13.5
- Lack of understanding about common, life-threatening lung disease that affects millions - 13.4

COPD - recent related articles/news stories:

- Soy, tofu, sprouts can improve COPD symptoms
- Marijuana smoking increases COPD risk for tobacco smokers
- Helium and exercise help COPD patients breathe easier
- COPD hospitalizations on the rise in US
- Indoor pollution in homes in China causing respiratory diseases

»»   Lead :: Cost Plus World Market recalls Red, Blue, Green, and Yellow Speckleware Beverage Containers
««   HIV :: GSK gives consent for generic version of HIV/AIDS medicine for use in Rwanda

Home | Cancer | Therapies | Diet | Herbs | Heart | Skin | Cosmetic Surgery | Arthritis | Allergies | Eyes | GIT | Glossary | List

AYUSH = Ayurveda - Yoga - Unani - Siddha - Homeopathy -- Health articles

The information provided on SpiritIndia.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician. Spirit India comply with the HONcode principles for trustworthy health information.
Health, Business, Science, Sports, Entertainment, Technology
©2002-2009 SpiritIndia.com