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  • News Brief for December 2015 [hide all summaries]
    (December 2015)
    In our news brief this month, we discuss Public Citizen's recent petition to the Food and Drug Administration to correct the labeling of a new drug approved for treatment of an uncommon sleep disorder in totally blind people. The agency mistakenly approved a label that expanded the drug's use to nonblind patients.

Additional Information from Public Citizen

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  • [hide all summaries]
    Public Citizen petitions the Food and Drug Administration (FDA) to reverse its decision to expand the approval of the sleep medication tasimelteon (Hetlioz) to patients who are not blind, as the relevant clinical trials for the drug were conducted only in totally blind patients with non-24-hour sleep-wake disorder. The petition also requests that FDA include certain animal toxicity data in the drug’s label.

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