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

Listen to this article

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.

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...

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

More from Approval Standards

PS-Pathways&Standards (Free-1): Industrial Chemicals Within Us - The Ubiquity of Industrial Products in the Human Body

Diversity Action Plans: What To Submit And When

Clinical Trial Diversity Action Plans Need Timely FDA Feedback, Groups Say

Califf: Rare Disease Hub Will Develop Methods To Guide Approvability Determinations

More from Pathways & Standards

Anvisa To Access US FDA-Reviewed Data For More Robust Evaluations In Brazil

Califf: Rare Disease Hub Will Develop Methods To Guide Approvability Determinations

Primary Biliary Cholangitis Drug Confirmatory Trials Aim To Avoid Hurdles That Tripped Up Ocaliva

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

Learn what's happening at the US FDA. On the go.

More from Approval Standards

More from Pathways & Standards