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Oh NOOH! Vanda’s Multi-Front Battle With US FDA Extends To Insomnia Drug Hetlioz

 
• By Bridget Silverman

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.

jet lag
The entire review process for Hetlioz's jet lag indication has been a headache for the FDA. • Source: Shutterstock

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.

Key Takeaways

  • The FDA proposed refusing to approve Vanda’s Hetlioz for insomnia with sleep initiation difficulty and published a notice for opportunity for hearing (NOOH) on the move...

The notice of opportunity for hearing (NOOH) published in the Federal Register 7 June describes the agency’s reasons for issuing a complete response letter on 4 March for a...

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