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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.

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