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# AstraZeneca Granted Pediatric Exclusivity for Symbicort
- URL: https://www.fdaweb.com/astrazeneca-granted-pediatric-exclusivity-for-symbicort/
- Published: 2017-01-27T12:00:00.000Z
- Updated: 2026-09-14T22:03:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137841

FDA has granted AstraZeneca six months pediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol, which is currently approved in the U.S. to treat asthma in patients 12 years and older and for the maintenance treatment of chronic obstructive pulmonary disease in adults. The agency’s decision was based on the evaluation of trials conducted in children with asthma aged six up to 12 years in response to an FDA request. Symbicort is a combination formulation containing budesonide, an inhaled corticosteroid, and formoterol, a long-acting beta-agonist bronchodilator, in a single inhaler.