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Pharmaceuticals / Submissions and Approvals

FDA Approves Dose of Lupin’s Budesonide Inhalation Suspension

Nov. 21, 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.

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