Jane S. Ricciuti, RPh, MS


March 19, 2003

In This Article

Antiasthmatic Agents

Pulmicort Respules
(budesonide inhalation suspension)

Manufacturer: AstraZeneca

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 01/10/03)

Clinical Summary: This supplemental approval changes the Pulmicort Respules (budesonide inhalation suspension) label, which includes changing the Pregnancy Category from "C" to "B." This change was based on a review of data from 3 Swedish registries covering over 2000 births from 1995-1997 (Swedish Medical Birth Registry; Swedish Registry of Congenital Malformations and the Swedish Child Cardiology Registry). These data indicate no increased risk for congenital malformations from the inhaled use of the corticosteroid, budesonide, during early pregnancy. Pulmicort Respules labeling will continue to advise that its use during pregnancy should be limited only if clearly needed.

Pulmicort Respules (budesonide inhalation suspension) Letter

Pulmicort Respules (budesonide inhalation suspension)


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