Drugs

FDA Approves Expanded COPD Use for Symbicort

FDA has approved AstraZeneca’s asthma therapy Symbicort (budesonide/formoterol fumarate dihydrate) inhalation aerosol 160/4.5 micrograms to reduce exacerbations of chronic obstructive pulmonary disease (COPD). Expanded approval was based on data from two Phase 3 studies of six-month (Trial 3 — The RISE Study) and 12-month (Trial 4) duration. “These exacerbation studies compared the efficacy of Symbicort pressurized metered dose inhaler (pMDI)160/4.5 micrograms and formoterol 4.5 micrograms, each administered as two inhalations twice daily in reducing COPD exacerbations in adult patients with moderate to very severe COPD,” the company says. Symbicort is also approved for asthma patients 12 years of age and older whose doctor has determined that their asthma is not well controlled with a long-term asthma control medicine such as an inhaled corticosteroid.

FDA Approves Expanded COPD Use for Symbicort

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