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

 
• By Brenda Sandburg
  
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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

Vanda Pharmaceuticals, Inc.’s battles with the US Food and Drug Administration have intensified with the agency’s rejection of its application to extend the indication for Hetlioz (tasimelteon) to treatment of jet lag disorder. The company is bypassing further litigation in district court and appealing the agency’s decision to the US Court of Appeals for the District of Columbia Circuit.

Mihael Polymeropoulos, president, CEO, chair, and co-founder of Vanda, said in an interview that the company had sued FDA in...

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