JAZZ - Avadel Pharmaceuticals' Promising FT218 Trial Offsets Decline In Its Legacy Business
Introduction
Avadel Pharmaceuticals (AVDL) was once a niche-drug player which pursued re-certification of products marketed before the FDA required drugs to demonstrate safety for approval in 1938. Prior to this time, adulterated or mislabeled drugs were prohibited from sale by the FDA, but the organization did not require that drugs be approved by it before commercialization. In 2006, the administrative body decided to create an incentive for pharmaceutical companies to establish both efficacy and safety in drugs operating under such regulatory loophole in exchange for granting these products marketing exclusivity until the approval