DC ap­peals court quash­es Nos­trum's suit against FDA, ex­plain­ing CRLs are not fi­nal re­jec­tions

A Mis­souri-based phar­ma com­pa­ny, once at the cen­ter of a Shkre­li-es­que gener­ic drug pric­ing scan­dal, just lost its chance to chal­lenge the FDA’s com­plete re­sponse let­ter for its gener­ic drug theo­phylline, which is used to treat asth­ma and oth­er res­pi­ra­to­ry con­di­tions.

The court ruled that it can­not take ac­tion on the suit as there’s a “statu­to­ry bar­ri­er” to the court’s re­view of com­plete re­sponse let­ters be­cause they aren’t tech­ni­cal­ly fi­nal.

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