Van­da takes FDA to court again, this time seek­ing more in­fo on a re­jec­tion let­ter

Af­ter a pre­vi­ous court loss to FDA in ear­ly 2020 over a clin­i­cal hold, Van­da Phar­ma­ceu­ti­cals re­turned to sue the agency again last week in the same DC dis­trict court, al­leg­ing this time that the agency is wrong­ful­ly with­hold­ing parts of a re­jec­tion let­ter for a new in­di­ca­tion for its sleep drug Het­lioz (tasimelteon) for jet lag.

The com­pa­ny re­ceived the com­plete re­sponse for its sN­DA for Het­lioz in Au­gust 2019, but the let­ter con­tained few de­tails on what Van­da need­ed to cor­rect course, ac­cord­ing to the com­pa­ny.

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