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From the Food and Drug Administration
October 4, 2000

New Inhaled Corticosteroid

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JAMA. 2000;284(13):1640. doi:10.1001/jama.284.13.1640-JFD00008-2-1

The FDA has approved budesonide inhalation suspension (Pulmicort Respules, AstraZeneca Group, Wayne, Pa) as maintenance and prophylactic therapy for asthma in children aged 1 to 8 years. The product, a sterile suspension for inhalation via jet nebulizer, contains the first anti-inflammatory corticosteroid approved for inhalation in children younger than 4 years.

Approval of the micronized budesonide inhalation suspension was based on three double-blind, placebo-controlled, randomized clinical trials of 12 weeks duration. The analysis included 946 patients who were aged 1 to 8 years and had persistent asthma.

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