Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da takes is­sue with FDA's re­lay of de­fi­cien­cies for new Het­lioz in­di­ca­tion

Van­da Phar­ma­ceu­ti­cals said on Mon­day that the FDA no­ti­fied the com­pa­ny of sev­er­al de­fi­cien­cies in the sup­ple­men­tal new drug ap­pli­ca­tion for its in­som­nia med­ica­tion Het­lioz, which means the agency can­not ap­prove the drug im­me­di­ate­ly.

The new in­di­ca­tion for Het­lioz — to treat in­som­nia char­ac­ter­ized by dif­fi­cul­ties with sleep ini­ti­a­tion — ran in­to a road­block, but Van­da said that the FDA did not dis­close any de­fi­cien­cies to the com­pa­ny and this is not a for­mal de­ci­sion.

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