FDA Approves Dose of Lupin’s Budesonide Inhalation Suspension

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.