www.fdanews.com/articles/68168-neurobiological-gains-fast-track-status-for-antistroke-treatment-viprinex
Neurobiological Gains Fast-Track Status for Antistroke Treatment Viprinex
January 31, 2005
Neurobiological Technologies has been granted fast-track status by the FDA for the investigational drug, Viprinex for its intended use in patients suffering from ischemic stroke.
Viprinex (ancrod) is under development for decreasing disability in patients with acute nonhemorrhagic stroke, treated within six hours of symptoms.
The fast-track designation provides for expedited regulatory review for new drug candidates demonstrating the potential to address unmet medical needs for the treatment of serious or life-threatening conditions.