Vanda Pharmaceuticals “perplexed” by FDA rejection of jet lag drug

Discussion in 'Pharma/Biotech Companies - In the News' started by cafead, Aug 20, 2019 at 10:12 AM.

  1. #1 cafead, Aug 20, 2019 at 10:12 AM
    cafead

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    via The FDA has issued a dreaded Complete Response Letter to Vanda Pharmaceuticals, rejecting the company’s jet lag drug Hetlioz (tasimelteon).

    Washington DC-based Vanda said that the regulator had ruled that the measures used in trials to demonstrate improved sleep are of “unclear clinical significance”.

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