Lupin receives FDA approval for Budesonide Inhalation Suspension, 0.5 mg/2 mL

Lupin announced that it has received approval for Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampules from the United States Food and Drug Administration (FDA) to market a generic version of AstraZeneca Pharmaceuticals LP’s (AstraZeneca) Pulmicort Respules Inhalation Suspension, 0.5 mg/2 mL.

Lupin’s Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampules is the generic version of AstraZeneca’s Pulmicort Respules Inhalation Suspension, 0.5 mg/2 mL. It is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.

Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampoules had annual sales of approximately USD $474.5 million in the US.