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Mylan Confident On Advair Generic First-Round Approval

 
• By Jessica Merrill

President Rajiv Malik said there has been “huge movement” at the agency around executing on the first ANDA for a generic version of GlaxoSmithKline’s blockbuster Advair.

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Mylan NV President Rajiv Malik said the company is confident it will secure a first round approval for a generic version of GlaxoSmithKline PLC’s blockbuster asthma drug Advair Diskus (fluticasone/salmeterol).

The company’s ANDA for generic Advair is pending at the FDA with a GDUFA (Generic Drug User Fee Act) action...

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