Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da sues FDA yet again, ac­cus­es fed­er­al agency of de­lay­ing post-CRL hear­ing

Van­da Phar­ma­ceu­ti­cals has filed yet an­oth­er law­suit against the FDA — and once again re­lat­ed to the drug it’s hop­ing to ex­pand in­to jet lag dis­or­der.

The se­r­i­al plain­tiff ac­cused the agency of fail­ing to give Van­da a hear­ing to de­ter­mine if it can add a jet lag dis­or­der in­di­ca­tion to Het­lioz, Van­da’s FDA-ap­proved drug to treat Non-24, a cir­ca­di­an rhythm dis­or­der in which a pa­tient’s in­ter­nal clock is mis­matched to the 24-hour day/night cy­cle.

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