Lupin has received the Food and Drug Administration’s clearance for budesonide inhalation suspension 0.5 mg/2 mL single-dose ampules.
The product 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 age 12 months old to 8 years old.
Budesonide inhalation suspension 0.5 mg/2 mL single-dose ampules had a market value of approximately $474.5 million, according to September 2018 IQVIA data.