FDA Hands Lannett Goal Date On Generic Advair

Lannett: Anticipate More Than One Review Cycle

 
• By Dean Rudge
  
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Lannett continues to eye the potential launch of its partnered Advair generic next year, after the lucrative respiratory asset was accepted for filing by the FDA.

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Lannett has two significant respiratory assets • Source: Shutterstock

The US Food and Drug Administration has accepted for filing Lannett’s application for a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol), although the US-based firm continues to anticipate “more than one FDA review cycle of this opportunity given the inherent complexity associated with a drug/device combination inhalation product.”

Lannett’s abbreviated new drug application product – developed in partnership with China’s Respirent Pharmaceuticals – was assigned a goal date...

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