Jazz sues FDA, HHS over ri­val nar­colep­sy drug ap­proval

Jazz Phar­ma­ceu­ti­cals is su­ing the FDA and HHS in fed­er­al court, ask­ing a judge to block what it called an “un­law­ful” ap­proval by fed­er­al reg­u­la­tors of a ri­val nar­colep­sy prod­uct.

Jazz filed a law­suit against the agen­cies in US Dis­trict Court for the Dis­trict of Co­lum­bia Thurs­day, al­leg­ing the ap­proval of Avadel Phar­ma­ceu­ti­cals’ Lum­ryz, a ri­val prod­uct to its own nar­colep­sy drug, is un­law­ful due to pro­tec­tions on its own drug un­der the Or­phan Drug Act (ODA).

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