1. Generics Bulletin

Vanda’s Hetlioz Suit Against FDA Largely Dismissed For Lack Of Ripeness

DC Court Concludes That Agency Evaluating Same Scientific Questions In Vanda Petition

 
• By Dean Rudge

“FDA regulations may require Vanda to exhaust its citizen petition before proceeding with this legal challenge insofar as it presents ‘additional information or views’ that were not placed before the agency when it approved MSN’s ANDA,” a US federal district court found, as it agreed to the agency’s motion to dismiss Vanda’s Administrative Procedure Act claims over generic tasimelteon.

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• Source: Shutterstock

A US federal district court has dismissed Vanda’s lawsuit against the US Food and Drug Administration that alleged the agency’s approval of MSN Laboratories’s generic rival to the originator’s Hetlioz (tasimelteon) sleep disorder drug was unlawful and poses serious safety risks to public health.

US District Court for the District of Columbia judge Christopher Cooper found that Vanda’s lawsuit was unripe for judicial review because the FDA is currently evaluating the same scientific questions presented in Vanda’s suit through its assessment of the

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