www.fdanews.com/articles/189259-fda-approves-dose-of-lupins-budesonide-inhalation-suspension
FDA Approves Dose of Lupin’s Budesonide Inhalation Suspension
November 20, 2018
Lupin received another approval from the FDA for its Budesonide inhalation suspension, a generic version of AstraZeneca’s long-term maintenance treatment, Pulmicort Respules, used to control and prevent asthma symptoms in children.
The agency approved the 0.5mg/2 mL single-dose ampules of Budesonide’s inhalation suspension for use in children 12 months to eight years of age.
The generic is not an adequate treatment for a severe asthma attack and should only be used with a jet nebulizer device connected to an air compressor, the agency said.