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Cipla Claims Success With Advair Trial

Indian Firm Has Warned FDA Review Could Last Two Years

 
• By Dean Rudge

Cipla is celebrating an “important milestone” for the company after the successful completion of a Phase III clinical trial comparing its proposed Advair generic with GSK’s brand in the US. Management has cautioned that approval will be a way off yet, however.

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Cipla says the US market for Advair was worth almost $3bn over the last 12 months • Source: Shutterstock

Cipla is a stage closer to making headway in the multi-billion-dollar Advair Diskus (fluticasone/salmeterol) market in the US, after wrapping up successfully its Phase III clinical trial to demonstrate equivalence between the Indian firm’s proposed generic product and GlaxoSmithKline’s powerhouse brand.

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