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Home » Court Rules FDA Must Divulge Internal Deliberations on Vanda’s Hetlioz sNDA
Court Rules FDA Must Divulge Internal Deliberations on Vanda’s Hetlioz sNDA
A federal court has ruled the FDA must share with Vanda Pharmaceutical its internal deliberation notes on why it denied Vanda’s supplemental new drug application (sNDA) for its sleep-disorder drug Hetlioz (tasimelteon) for jet lag.