On February 2, 2021, Lassman Law+Policy submitted a Citizen Petition to the Food and Drug Administration (FDA) on behalf of Amneal Pharmaceuticals LLC. The petition asks FDA to refuse to approve proposed dosing modifications for vasopressin based on patient genotype because they appear to be unnecessary, without adequate scientific support, and potentially unsafe for patients treated for vasodilatory shock. FDA has 180 days to respond to the Citizen Petition.
Lassman Law+Policy was privileged to represent Braeburn, Inc. (with co-counsel Goodwin) in securing this U.S. District Court ruling overturning an FDA decision on 3-year exclusivity as unreasonable and arbitrary and capricious. The decision, issued on July 22, 2019, orders FDA to reconsider "with deliberate speed" Braeburn's application for approval of an innovative new injectable treatment for opioid use disorder. Read all about it here.