AstraZeneca strikes out on effort suing FDA to halt generic Seroquel
This article was originally published in Scrip
Executive Summary
AstraZeneca has failed in its last ditch effort to enjoin the US FDA from granting final ANDA approval for generic versions of the company's antipsychotic Seroquel (quetiapine fumarate) until 2 December, when it claimed that regulatory exclusivity expires on key clinical trial associated with warning language, or at least until a federal court had an opportunity to review imminent FDA action.