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Keeping Track: FDA Approves First Generic Advair, But Alkermes And Sunovion Land CRLs

 
• By Michael Cipriano and Bridget Silverman

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

It was a time for Mylan NV and the US FDA to celebrate, as the agency gave its first ever blessing to a generic of the hard-to-copy Advair Diskus (fluticasone propionate and salmeterol inhalation powder). Advair Diskus, along with EpiPen (epinephrine injection), have long epitomized the difficulties of copying complex products.

At least two companies were hit with complete response letters (CRLs):Alkermes PLC and Sunovion Pharmaceuticals Inc

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