Lupin receives FDA blessing for generic Pulmicort

11/13/2018
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.
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