Van­da ap­peals to FDA again, in­sist­ing on sN­DA hear­ing in lat­est wrin­kle in jet lag drug saga

Just over a month af­ter CDER di­rec­tor Pa­trizia Cavaz­zoni made clear that she and FDA were look­ing to shut down Van­da Phar­ma­ceu­ti­cals’ sN­DA re­quest, the biotech is call­ing foul.

Van­da at­tor­ney Paul Hugh­es sub­mit­ted a let­ter to FDA last week ask­ing the agency to fol­low fed­er­al statute and set up a hear­ing re­gard­ing its sN­DA by no lat­er than Christ­mas Eve.

The re­quest fol­lows FDA’s re­jec­tion in Au­gust of the sN­DA for Het­lioz (tasimelteon) as a treat­ment of jet lag dis­or­der, on which Van­da said it ac­cept­ed the op­por­tu­ni­ty for a hear­ing. Van­da has al­ready sued the FDA twice for this de­layed hear­ing.

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