Vanda Appeals FDA’s Denial Of Hetlioz Jet Lag Application As It Is Hit With CRL For Insomnia

 
• By Brenda Sandburg

Vanda CEO tells the Pink Sheet that the firm is going straight to appellate court to refute agency’s rejection of jet lag indication for Hetlioz. Similar battles may lie ahead over Vanda’s applications on Hetlioz for insomnia and tradipitant for gastroparesis.

Jet lag
US FDA rejects Vanda's application for a jet lag indication for Hetlioz and issues complete response letter on insomnia application • Source: Shutterstock

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