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Mylan's Generic Advair FDA Filing Puts Added Squeeze On GSK

 
• By Sten Stovall

The increasing urgency for GlaxoSmithKline PLC to build up its overall respiratory portfolio was underscored when Mylan NV confirmed it has submitted an abbreviated new drug application (ANDA) to the FDA for launch of the first generic alternative to GSK's top-selling Seretide Evohaler (salmeterol xinafoate + fluticasone propionate), known in the US as Advair Diskus.

The increasing urgency for GlaxoSmithKline PLC to build up its overall respiratory portfolio was underscored when Mylan NV confirmed it has submitted an abbreviated new drug application (ANDA) to the FDA for launch of the first generic alternative to GSK's top-selling Seretide Evohaler (salmeterol xinafoate + fluticasone propionate), known in the US as Advair Diskus.

The US-based company, which launched the first generic alternative to GSK's blockbuster in Britain last June, said in a statement...

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