Mylan’s Generic Advair Delay Gives Leverage To Rivals
Mylan received a “complete response” letter from FDA on its application for a generic version of GSK’s blockbuster Advair, offering scarce details on the reason why or possible length of the delay.
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Agency declined to say whether ANDA sponsors would need to meet requirements requested by Sandoz; Mylan's generic user fee date is March 28.
Mylan Plans Summer Launch For Advair Generic, Now Called Wixela Inhub
Wixela Inhub could be the first interchangeable generic version of the blockbuster asthma drug on the US market if it is approved by FDA.
Teva AirDuo Poised To Be A Discounted, But Not Interchangeable, Version Of Advair
FDA approved Teva’s AirDuo RespiClick, which contains the active ingredients in GlaxoSmithKline’s Advair, but in the RespiClick device, which means it will not be an interchangeable generic.