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US FDA Releases Slew Of Guidances On A Fell Day For Complex Generics

 
• By Michael Cipriano

New and updated guidances are good news for ANDA sponsors, but timing – coming the day Sandoz announced a CRL for its Advair copy – underscores challenges that developers of complex generics face.  

Maze
Getting to ANDA approval can sometimes feel like getting through a labyrinth.

The US FDA has handed Novartis AG's generics unit Sandoz Inc. a complete response letter for copycat of Advair Diskus (fluticasone propionate and salmeterol)‎, highlighting the broader challenges of replicating complex drugs raised by agency Commissioner Scott Gottlieb.

GlaxoSmithKline PLC's Advair – a combination product for the treatment of asthma and airflow obstruction – has become the poster

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