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Mylan Preparing Response To Generic Advair CRL, And It Needs A Win

 
• By Jessica Merrill

After meeting with FDA to discuss the status of its Advair generic application in the US, Mylan said it will not have to conduct additional clinical trials and is on target to respond to the complete response letter soon.

Arrows miss target

Mylan NV aims to get its application for a generic version of GlaxoSmithKline PLC's asthma blockbuster Advair Diskus (fluticasone/salmeterol) back in the US FDA's court soon. During the company's second quarter earnings call Aug. 9, President Rajiv Malik said the company would be ready to respond to the complete response letter received from FDA "in the next couple of weeks."

The update on the important application comes after Mylan met with FDA to discuss the CRL and clarified that it...

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