Jaun­dice drug for in­fants re­ject­ed by FDA, shak­ing up Mallinck­rodt's plans for new­ly-ac­quired stannso­porfin

It’s of­fi­cial. Mallinck­rodt’s new­ly-ac­quired jaun­dice drug just got kicked back by the FDA.

The Eng­land-based drug­mak­er was ex­pect­ing omi­nous news af­ter the agency’s ad­vi­so­ry com­mit­tee vot­ed strong­ly against the drug’s ap­proval back in May. The com­pa­ny just bought the in­ves­ti­ga­tion­al med — called stannso­porfin — from In­faCare last year. It’s a heme oxy­ge­nase in­hibitor de­signed to pre­vent jaun­dice in in­fants by turn­ing down the di­al on the for­ma­tion of biliru­bin, an or­ange-yel­low pig­ment formed in the liv­er by the break­down of he­mo­glo­bin and ex­cret­ed bile.

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