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Vanda Sues US FDA For Documents Backing Complete Response For Hetlioz Jet Lag Indication

 
• By Brenda Sandburg

FOIA exemption does not apply to medical and statistical reviews of its sNDA, company claims. It says it needs the information to adapt its development program and determine if the agency made an error.

Jet lag
Vanda fights FDA for documents pertaining to jet lag indication for Hetlioz • Source: Alamy

Nearly three years after receiving a complete response letter from the US Food and Drug Administration denying its application for a jet lag disorder indication for Hetlioz, Vanda Pharmaceuticals, Inc. filed suit to obtain the agency’s review documents.

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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US FDA Spikes Vanda’s Hetlioz For Insomnia, Lack Of Well-Controlled Trial ‘Fatal’

 
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Acting Commissioner Sara Brenner rejected the company’s request for a hearing, saying the lack of an adequate and well-controlled trial showing tasimelteon's effectiveness in treating sleep-onset insomnia is “fatal to the application.”

Better Luck Next Year: US FDA CRLs May Be Rising, But Are Not The End Of The Story

 
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Prospects are promising for many of the 16 novel candidates that received complete response letters in 2024 after half of the 2023 CRL class was approved the following year.

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