En­do sues FDA over its han­dling of gener­ic Adren­a­lin ap­provals

En­do Phar­ma­ceu­ti­cals is su­ing the FDA over its ap­proval of a gener­ic ver­sion of En­do’s Adren­a­lin in­jec­tions to treat al­ler­gic re­ac­tions, re­quest­ing an emer­gency stay on the agency’s de­ci­sion.

In a 32-page law­suit filed in the US Dis­trict Court for the Dis­trict of Co­lum­bia on Mon­day, En­do ar­gues that the FDA un­law­ful­ly ap­proved a gener­ic ver­sion of ep­i­neph­rine, which En­do mar­kets as Adren­a­lin. Ep­i­neph­rine is an in­jec­tion used in the clin­i­cal set­ting to treat ana­phy­lax­is and to in­crease blood pres­sure in pa­tients with low blood pres­sure due to sep­tic shock. The FDA grant­ed fi­nal ap­proval for a ver­sion of BPI Labs’ ep­i­neph­rine in Feb­ru­ary.

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