Fast track status indicates that the FDA has recognized that Sabril is intended for the treatment of a serious or life-threatening condition for which there are no available treatments and which demonstrates the potential to address unmet medical needs.
Tim Cunniff, vice president, global gegulatory affairs, pharmacovigilance, and clinical quality assurance at Ovation, said: “We believe that this fast track designation for Sabril will accelerate our efforts to bring to market a treatment option for the hundreds of thousands of people who suffer from dependence on cocaine and methamphetamine.”