In a BSE filing today, Cipla said "it has received final approval for its abbreviated new drug application (ANDA) for Budesonide Inhalation Suspension, 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL from the United States Food and Drug Administration (USFDA)".
The approved product is a generic version of Astrazeneca's Pulmicort Respules, it added.
Pulmicort Respules are indicated for maintenance treatment of asthma and as prophylactic therapy in children of 12 months to 8 years.
Citing IMS Health data, Cipla said Pulmicort Respules and generic equivalents had US sales of approximately USD 825 million for the 12 months to September 2017.
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