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MSN Put On Hold As DC Appeals Court Freezes Generic Entresto Approval

Novartis Has Met ‘Stringent Requirements’ For Stay Of ANDA Approval Pending Appeal

 
• By Dean Rudge

MSN Laboratories will be unable to move forward – for now – with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US after the originator won a stay on the firm’s ANDA pending appeal from the US Court of Appeals for the District of Columbia Circuit.

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• Source: Shutterstock: studiostoks

MSN Laboratories’ US Food and Drug Administration approval for its generic version of Novartis’ multi-billion-dollar Entresto (sacubitril/valsartan) heart failure powerhouse has been stayed for now by an appeals court in Washington D.C., in the latest twist in the firms’ complex, ongoing litigation.

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