Lupin receives USFDA approval for Budesonide Inhalation Suspension

Lupin has received approval for its Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampules from the United States Food and Drug Administration (USFDA) 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 Ampules had annual sales of approximately $474.5 million in the US (IQVIA MAT September 2018).

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.