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Hikma’s Latest Advair Setback Pushes It Closer To Rivals

Further CRL From FDA Is ‘Minor’; Cipla Filed ANDA In May

 
• By Dave Wallace

Hikma has received another setback on its US application for a generic version of Advair following a minor complete response letter from the FDA. The resulting delay will push back the expected final response date from the agency closer to that expected by rival Cipla, which filed an ANDA earlier this year.

Runner
Hikma is still leading the race to get the second US generic Advair • Source: Shutterstock

A further setback for Hikma’s proposed generic version of GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) in the US has reshaped the race to get the next US Food and Drug Administration approval for a rival to the respiratory blockbuster.

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