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US Setback For Lupin’s GxProAir But Application Has 'Moved Ahead'

 
• By Anju Ghangurde

Lupin is staring at stretched launch timelines in the US for its generic ProAir following a Complete Response Letter, but the company maintains that its application has progressed and the market opportunity for the product remains attractive.

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Setback For Lupin's Ggeneric ProAir In US • Source: Shutterstock

Lupin Ltd. has received from the US FDA a Complete Response Letter (CRL) for its generic version of Teva Pharmaceutical Industries Ltd.'s ProAir (albuterol sulfate) metered dose inhaler, a key asset that was expected to help propel the Indian firm’s growth in the inhalation segment in the US.

Lupin was hoping to hit the US market with its generic ProAir in the second half of fiscal 2019-20 and...

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