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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.

The Indian firm won approval for its Entresto generic in late July in the wake of the agency denying a...

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