Mylan’s Wixela is ‘imminent’

Mylan believes that US Food and Drug Administration (FDA) approval of its Wixela Inhub generic alternative to GlaxoSmithKline’sAdvair Diskus (fluticasone/salmeterol) respiratory blockbuster is “imminent”. “Mylan confirms it has not received any new information request or complete response letter (CRL) from the FDA,” the company said in a statement issued on 22 October.

Mylan believes that US Food and Drug Administration (FDA) approval of its Wixela Inhub generic alternative to GlaxoSmithKline’sAdvair Diskus (fluticasone/salmeterol) respiratory blockbuster is “imminent”. “Mylan confirms it has not received any new information request or complete response letter (CRL) from the FDA,” the company said in a statement issued on 22 October.

In August, Mylan had indicated that it had an FDA action date for Wixela Inhub in “mid-October”, having responded to...

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