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

 

• A federal court granted final judgment in favor of Vanda Pharmaceuticals Inc's 
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   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.
• 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.

https://www.benzinga.com/general/biotech/23/03/31545006/court-favors-vanda-in-case-against-fda-over-detail-disclosure-of-rejection-of-sleep-disorder-drug