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

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 district court to get the agency to decide whether to grant it a hearing on its proposal to deny the application or deny its