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MSN Generic Entresto Launch In Doubt After US Appeals Court Stops Approval

 
• By Dean Rudge

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

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A federal appeals court disagreed with lower court rulings on the Entresto generic. • Source: Shutterstock: studiostoks

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

The Indian firm won approval for its Entresto generic in late July after the agency denied two Novartis citizen petitions on Entresto on the “same active

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