As­traZeneca or­dered back in­to the penal­ty box on ZS-9 af­ter an­oth­er re­jec­tion on man­u­fac­tur­ing mal­func­tion

This one will re­al­ly hurt at As­traZeneca.

Ten months af­ter the phar­ma gi­ant was side­lined on ZS-9 by man­u­fac­tur­ing is­sues, the team at As­traZeneca is once again be­ing put in the penal­ty box. The FDA has re­ject­ed the hy­per­kalemia drug — just as it did last May — fol­low­ing an in­spec­tion of the man­u­fac­tur­ing cen­ter.

The agency isn’t look­ing for any new tri­als, but As­traZeneca will need to go back to the draw­ing board to fig­ure out what’s wrong at its man­u­fac­tur­ing fa­cil­i­ty. And that could take un­til ear­ly 2018.

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