Court Favors Vanda In Case Against FDA Over Detail Disclosure Of Rejection Of Sleep Disorder Drug

A federal court granted final judgment in favor of Vanda Pharmaceuticals Inc's VNDA Freedom of Information Act (FOIA) case requesting records created by the FDA during its review of Vanda's application seeking approval of Hetlioz (tasimelteon).
DC District Court Judge granted Vanda Pharma's request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.
Also Read: Vanda Pharma's Antipsychotic Shows Improved Severity In Bipolar Disorder.
Vanda filed the lawsuit to compel the FDA to produce certain records relating to its denial of Vanda's supplemental marketing application for Hetlioz for the jet lag disorder.
In 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in 2019 and refused to disclose those records.
Vanda sued in April 2022, saying it has a right to know what else the rejection and review documents contain.
As part of its ruling, the federal court issued a final and appealable order in Vanda's favor, denying the FDA's cross-motion for summary judgment.
Price Action: VNDA shares closed at $6.79 on Tuesday.