FDA denies hearing to Vanda on jet lag indication for sleep disorder drug
05 Mar 2024
The FDA on Tuesday
turned down
Vanda Pharmaceuticals’ request for a hearing on issues the agency found with the company’s application for a jet lag indication for its sleep disorder drug Hetlioz, another blow to the company and its strained relationship with the agency.
The FDA’s decision nixes chances that Vanda’s Hetlioz, which is approved for other sleep disorders, will be granted an indication for jet lag disorder. The FDA cited issues with the endpoints used in the trials, said there was no debate about the facts and data for the drug, and that it wasn’t in the public interest to reconsider.
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