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news.UK-based SkyePharma has received approval from the German pharmaceutical regulatory authority for its formoterol fumarate inhalation powder, or Foradil Certihaler, developed for the treatment of asthma and chronic obstructive pulmonary disease.
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The new powder was submitted for regulatory review in Europe and the US on a country-by-country basis beginning in December 2002 and has now been approved in Switzerland, Austria, Finland, Portugal and the Netherlands as well as in Germany. It has also been approved in five Latin American countries.
SkePharma produced the powder with Swiss firm Novartis Pharma, which is currently preparing to provide the Food and Drug Administration (FDA) with additional data.
Formoterol is the active ingredient in the powder. It is a beta2-agonist bronchodilator that combines an onset of action (within 5 minutes) with a long-lasting bronchodilation effect for 12 hours.
The Foradil line was developed to provide an option for asthma and chronic obstructive pulmonary disease (COPD) patients who require maintenance therapy with a long-acting bronchodilator.