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Three Strikes For Generic Advair With An FDA CRL For Sandoz

 
• By Jessica Merrill

Novartis' generic drug unit confirmed the receipt of a complete response letter from the US FDA for a generic version of GlaxoSmithKline's Advair, following similar CRLs for Mylan and Hikma.

Baseball Pitcher Throwing ball, selective focus

Novartis AG's Sandoz Inc. generic drug unit will not be the first to market with a generic version of GlaxoSmithKline PLC's big asthma seller AdvairDiskus (fluticasone/salmeterol) – at least not for now. Several generic drug makers are vying for the lucrative prize of being first to the US market, but the first three applications to reach the FDA for review have each been met with a complete response letter.

Sandoz is the latest to receive a CRL from FDA, the company confirmed Feb. 8. The agency issued CRLs to...

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• By Andrew McConaghie

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