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The investigational fixed-dose combination of ASMANEX and FORADIL, both of which are currently approved and marketed as individual products, is in Phase III development for the treatment of asthma and COPD.
The LABA products approved in the United States are Serevent (salmeterol) and Foradil (formoterol), which contain the LABA alone, and Advair (salmeterol plus fluticasone) and Symbicort (formoterol plus budesonide), which contain the LABA and an ICS.
The other, Foradil (formoterol) also works for 12 hours, "The long-acting bronchodilators are very effective in COPD, and the inhaled route is safer than oral doses for these patients who are older and have comorbidities," he said.
FORADIL AEROLIZER should only be used as additional therapy for patients not adequately controlled on other asthma controller medications.
Serevent and Foradil also are approved for COPD, so they will remain on the market, but the warnings about not using them without an ICS in patients with asthma likely will be strengthened.
FORADIL AEROLIZER, a long-acting beta2 agonist for asthma and chronic obstructive pulmonary disease.
Foradil Aerolizer (formoterol fumarate), made by Novartis AG, is included in the health advisory.
Comment: In a Novartis-supported study of 780 patients with COPD, Foradil was better than placebo and ipratropium bromide in improving lung function over 12 weeks.
A spokesperson for Novartis, the manufacturer (with Schering-Plough) of Foradil, said that the company was working with the FDA on the most appropriate language for the package label and medication guide.
The Committee recommended the continued availability of long-acting beta-2 agonists Advair (fluticasone propionate and salmeterol) and Symbicort (budesonide/formoterol fumarate dihydrate) but said Serevent (salmeterol xinafoate) and Foradil (formoterol fumarate) should no longer be used for treating asthma.