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Cipla's Advair Generic US Debut May Be Pushed Out But 'Value Intact'

 
• By Anju Ghangurde

Cipla to pursue two-site, de-risked filing approach for large respiratory assets even as it awaits an FDA compliance classification for its Indore facility, which will determine the launch timelines for its much-awaited generic Advair in the US.

Investors Await Clarity On gAdvair Launch Timeline • Source: Shutterstock

Launch timelines for Cipla Limited’s long-awaited generic (g) Advair (salmeterol/fluticasone) in the US now hinge on whether its Indore site in India makes the compliance cut, but the firm claimed that even if things don’t go its way, the value proposition for the product remains unaltered.

The inspection classification of the Indore site by the US Food and Drug Administration was expected around mid-May and an unfavorable outcome could push the gAdvair launch timeline out by...

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