“FDA regulations may require Vanda to exhaust its citizen petition before proceeding with this legal challenge insofar as it presents ‘additional information or views’ that were not placed before the agency when it approved MSN’s ANDA,” a US federal district court found, as it agreed to the agency’s motion to dismiss Vanda’s Administrative Procedure Act claims over generic tasimelteon.

Disputes over orphan and new clinical investigation exclusivity are among the early drug and biologic cases where legal filings cite the Loper Bright decision, which overturned the Chevron doctrine of deference to agency actions.

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.

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.