Jazz Challenges FDA on Lumryz Approval, Avadel Responds
By Alyx Arnett Jazz Pharmaceuticals is challenging the US Food and Drug Administration (FDA) in district court over the FDA’s recent approval of a competing new narcolepsy drug, Lumryz. In the filing in the United States District Court for the District of Columbia, Jazz alleges that, despite the orphan drug exclusivity protecting Jazz’s low-sodium oxybate…