Vanda’s Hetlioz Suit Against FDA Largely Dismissed For Lack Of Ripeness
DC Court Concludes That Agency Evaluating Same Scientific Questions In Vanda Petition
“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.
