Mihael Polymeropoulos, Vanda Pharmaceuticals CEO
Vanda wins court case against FDA over disclosure of CRL details for sleep drug
DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.
The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.
To read Endpoints News become a free subscriber
Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters