Vanda Pharmaceuticals, Inc. is escalating its struggle with the US Food and Drug Administration over complete response letters for new indications for its sleep disorder drug Hetlioz (tasimelteon) through a rarely-used procedure that provides a chance to request a hearing on the agency’s proposed refusal to approve an application.
Oh NOOH! Vanda’s Multi-Front Battle With US FDA Extends To Insomnia Drug Hetlioz
The notice of opportunity for hearing on the US FDA’s proposal not to approve an insomnia sNDA for Vanda’s Hetlioz opens another front in the company’s aggressive campaign against complete response letters and generic competition to the sleep disorder drug.
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