FDA de­nies hear­ing to Van­da on jet lag in­di­ca­tion for sleep dis­or­der drug

The FDA on Tues­day turned down Van­da Phar­ma­ceu­ti­cals’ re­quest for a hear­ing on is­sues the agency found with the com­pa­ny’s ap­pli­ca­tion for a jet lag in­di­ca­tion for its sleep dis­or­der drug Het­lioz, an­oth­er blow to the com­pa­ny and its strained re­la­tion­ship with the agency.

The FDA’s de­ci­sion nix­es chances that Van­da’s Het­lioz, which is ap­proved for oth­er sleep dis­or­ders, will be grant­ed an in­di­ca­tion for jet lag dis­or­der. The FDA cit­ed is­sues with the end­points used in the tri­als, said there was no de­bate about the facts and da­ta for the drug, and that it wasn’t in the pub­lic in­ter­est to re­con­sid­er.

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