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Despite Endpoint Furor, FDA Panel Unanimously Backs Vanda’s Hetlioz

By Catherine Shaffer
Staff Writer

Thursday, November 14, 2013

A meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that Vanda Pharmaceuticals Inc.’s candidate for non-24-hour sleep-wake disorder, Hetlioz (tasimelteon), was safe and voted 10-0, with one abstention, that the company provided substantial evidence of efficacy for the drug.

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