FDA approves once-a-day inhaler from Glaxo

The Food and Drug Administration says it has approved a new once-a-day inhaler drug from GlaxoSmithKline for patients with chronic lung disease.

The agency cleared the Breo Ellipta inhaler for long-term use and to control flare-ups in patients with chronic obstructive pulmonary disorder, often called smoker's cough. The lung ailment can cause a number of breathing problems, including and emphysema.

Breo Ellipta delivers a combination of two drugs that reduce inflammation in the lungs and relax airways to ease breathing. The drug carries a warning that it is not approved for asthma.

Glaxo, a leader in respiratory medicine, already sells the asthma treatment Advair, its best-selling product with more than $4 billion in sales per year. The British drugmaker collaborated on the inhaler with South San Francisco-based Theravance.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

US panel backs inhaler drug for lung disease

Apr 17, 2013

A panel of U.S. respiratory experts voted Wednesday in favor of approving an experimental inhaler drug from GlaxoSmithKline and Theravance for treating chronic lung disease.

Tudorza pressair approved for COPD

Jul 24, 2012

(HealthDay) -- The Tudorza Pressair (aclidinium bromide) inhaler has been approved by the U.S. Food and Drug Administration to treat narrowing of the lung airways associated with chronic obstructive pulmonary disease (COPD) ...

Inhaler approved for cystic fibrosis patients

Mar 25, 2013

(HealthDay)—The TOBI Podhaler (tobramycin inhalation powder) has been approved by the U.S. Food and Drug Administration to treat cystic fibrosis patients infected with Pseudomonas aeruginosa, a bacterium that can damage ...

Drugmaker GSK posts slumping Q1 profits

Apr 24, 2013

British drugs firm GlaxoSmithKline on Wednesday said its first-quarter net profit tumbled by almost a third, with the group hit by falling sales and a poor economic climate.

Recommended for you

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

Physicians warned about counterfeit medical devices

Jul 24, 2014

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

User comments