AstraZeneca submits an sNDA for Symbicort for treatment of asthma in children as young as 6

Wilmington, DE June 4, 2008 AstraZeneca (NYSE: AZN) today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for th...

Study analyzed SYMBICORT in children with persistent asthma

Wilmington, DE May 20, 2008 A new 12-week study2examined safety and efficacy measures of the maintenance combination asthma therapy, SYMBICORT (budesonide/formoterol fumarate dehydrate) Inhalation Aerosol,2 in treating mild to moderate persistent asthma in children ages 6 to 15 years old2 who we...

New Data Shows Significant Asthma Control With Symbicort

New data showed that using SYMBICORT? for asthma provides a rapid and clinically significant bronchodilatory response and improvement// in lung function within 15 minutes after administration. In addition, these data demonstrated that in comparison to its monocomponents (budesonide and formo...

Cadient Group Wins Nine Communicator Awards

...T Program -- Email Marketing Category -- Cadient Group was honored for its symbicort Consumer Campaign for AstraZeneca. The agency developed a successful launch campaign of the symbicort brand to consumers, generating strong, early awareness of the new inhaled a...

Inhaled Corticosteroids Boost Pneumonia Risk in COPD

...ie Neff, a spokeswoman for AstraZeneca, noted that symbicort is not currently indicated for the treatment of CO...ed at the drug in COPD patients] demonstrated that symbicort was well-tolerated for six and 12 months respectiv... COPD," Edelman said. "Advair is the main one now, symbicort is likely to be approved for COPD by the FDA soon,...

St. Louis Named Top Asthma Capital for 2009

...mation visit www.astrazeneca-us.com . About symbicort symbicort is a combination therapy indicated for the long-te... asthma in patients 12 years of age and older.(7). symbicort is not indicated in patients whose asthma can be s...

Two Asthma Meds May Be Too Risky, FDA Panel Says

...recommend. That may help explain why Advair and symbicort were spared. Serevent contains just one active in...and fluticasone (an inhaled cortocosteroid), while symbicort contains formoterol and another steroid (budesonid...But a third FDA official concluded that Advair and symbicort are safe for adults, but that all four drugs shoul...

FDA Panel Mulls Safety of Asthma Meds

..., Foradil (formoterol), Serevent (salmeterol), and symbicort (formoterol, budesonide). Advair and symbicort are combination products containing both a long-ac...But a third FDA official concluded that Advair and symbicort are safe for adults, but that all four drugs shoul...

Advair's Patient Share in Newly Diagnosed Asthma Patients is Declining

... disease prior to progressing to a long-acting beta2 agonist (LABA)/ICS combination; and physician movement towards using AstraZeneca's newly launched symbicort as an alternative to Advair in later lines of therapy. The report also finds that surveyed physicians will continue to use Singulair first-lin...

Study Analyzed Long-Term SYMBICORT(R) Use in Children With Persistent Asthma

... symbicort Was Well Tolerated in 26-Week Study WILMINGTON, ... to 11 years old. The study examined the safety of symbicort in children for 26 weeks and also included efficac...on, the study showed that long-term treatment with symbicort resulted in significantly greater improvements in ...

Symbicort in Medical Technology

Newly Released Data on Onset of Effect and Patient Perception With SYMBICORT in Adults With Asthma

WILMINGTON, Del., Sept. 10 /PRNewswire-FirstCall/ -- Newly released results from two previously published studies demonstrated patients receiving the maintenance combination asthma therapy SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol achieved bronchodilation, or o...

AstraZeneca Responds to FDA Joint Advisory Committees' Recommendation on SYMBICORT(R)

... of AstraZeneca, said, "The safety and efficacy of symbicort have been demonstrated in numerous clinical trials...s and other public health matters. About symbicort in the U.S. SYMBICORT(R) (budesonide/formot...asthma and is available in two different inhalers, symbicort TURBUHALER and in the U.S. as...

Pivotal Data Showed SYMBICORT(R) Improved Lung Function in Adults with COPD

... Data also found symbicort opened airways in less than 15 minutes WILMINGTO...percent improvement in FEV1 within 15 minutes with symbicort as compared to budesonide and placebo on the day o...d SHINE Safety) The efficacy and tolerability of symbicort was assessed in a six-month, randomized, double-bl...

AstraZeneca Submits an sNDA for SYMBICORT(R) for the Treatment of Asthma in Children as Young as Age Six

...thma in pediatric patients ages 6 to 11 years old. symbicort is currently approved for the long-term maintenanc...se III trials assessing the efficacy and safety of symbicort pressurized metered-dose inhaler (pMDI) that inclu... inhaled corticosteroid therapy.(3) In this study, symbicort was compared to budesonide pMDI and formoterol dry...

Study Analyzed SYMBICORT(R) in Children with Persistent Asthma

...and rescue medication-free days in patients taking symbicort compared to those taking formoterol dry powder inh...rug Administration for the pediatric indication of symbicort in the first half of 2008. About the Study (Abst...K67) The safety profile and efficacy measures of symbicort were assessed during a 12-week randomized, double-...

AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication

...with Chronic Obstructive Pulmonary Disease (COPD). symbicort is currently approved for the long-term maintenanc... University of California, Los Angeles (UCLA). "If symbicort receives approval from the FDA to help manage COPD...al efficacy and safety trials, SHINE and SUN, with symbicort pressurized metered dose inhaler (pMDI).(2),(3) Of...

Study Compares Bronchodilatory Effects of SYMBICORT(R) and Advair in Adults With Asthma

... Data Showed Faster Onset with symbicort with Improved Lung Function within ...ceive once-daily treatment with two inhalations of symbicort (budesonide/formoterol pMDI) 80/4.5 micrograms, on...e minutes postdose were significantly greater with symbicort and albuterol pMDI compared to fluticasone propion...

Symbicort in Biological Technology

Novartis/Schering-Plough's Drug Will Replace AstraZeneca's Symbicort as Decision Resources' Clinical Gold Standard by 2012 for the Treatment of Asthma

A Therapy's Effect on Reduction of Exacerbations is the Attribute That Most Influences Physicians' Prescribing Decisions, According to a New Report from Decision Resources WALTHAM, Mass., Feb. 24 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for ph...

Cadient Group Brings Home the Gold and Two Bronze Aster Awards

... honored with a Bronze in the Total Advertising Campaigns' category for its symbicort Consumer Campaign for AstraZeneca in Wilmington, Del. Cadient Group developed a successful launch campaign of the symbicort brand to consumers, generating strong, early awareness of the new inhaled a...

FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)

... symbicort provides a new, fast-acting(1) combination treatme...S. Food and Drug Administration (FDA) has approved symbicort (budesonide/formoterol fumarate dihydrate) 160/4.5...SHINE (6-month) and SUN (12-month),(2) which found symbicort significantly improved lung function within five m...

New Patient Satisfaction Study With budesonide/formoterol Combination Therapy and fluticasone/salmeterol Combination Therapy in Adults With Asthma

...on that medication (N=335)(1). About SYMBICORT symbicort is a combination therapy indicated for the long-te...ars of age and older(2). Administered twice daily, symbicort is a combination of two proven asthma medications ... a rapid and long- acting beta2-agonist (LABA)(2). symbicort does not replace fast-acting inhalers and should n...