CDER strikes back at Van­da, dis­clos­es ra­tio­nale be­hind 2019 sN­DA re­jec­tion

It’s not of­ten that the FDA pub­licly ex­plains the ra­tio­nale be­hind its re­jec­tions, but the com­pa­ny the FDA is now open­ing up about has a liti­gious his­to­ry with the fed­er­al reg­u­la­tor.

Ac­cord­ing to a no­tice in the Fed­er­al Reg­is­ter to­day, CDER di­rec­tor Pa­trizia Cavaz­zoni is look­ing to refuse em­bat­tled biotech Van­da’s sN­DA for Het­lioz (tasimelteon). And that fil­ing doesn’t shy away from why the di­rec­tor plans to shut down the sN­DA.

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