AstraZeneca's asthma treatment approved by the FDA
The US Food and Drug Administration (FDA) has approved Symbicort (budesonide/formoterol) for the treatment of asthma in patients age 12 and older.
The US Food and Drug Administration (FDA) has approved Symbicort (budesonide/formoterol) for the treatment of asthma in patients age 12 and older.
Symbicort is a twice-daily asthma therapy combining budesonide, an inhaled corticosteroid, and formoterol, a rapid and long-acting beta2-agonist into one inhaler. The drug will be available in a pressurised metered dose inhaler (pMDI), the most commonly prescribed delivery device in the US market. This is the first country where the drug will be available in this type of device.
The FDA has approved two dose strengths for Symbicort and clinical studies have shown that both dosage strengths produced a greater improvement in lung function compared with the same doses of budesonide or formoterol administered alone, or a placebo.
The drug received European Mutual Recognition for the treatment of asthma in December 2000 and is currently approved in over 90 countries and has reached more than 5m patient years outside the US. AstraZeneca plans to launch it in the US in mid 2007.