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# FDA Approves Expanded COPD Use for Symbicort
- URL: https://www.fdaweb.com/fda-approves-expanded-copd-use-for-symbicort/
- Published: 2017-09-14T12:00:00.000Z
- Updated: 2026-09-14T22:50:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139630

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.