FDA accepts Adamas application for expanded use of Gocovri

The FDA accepts for review Adamas Pharmaceuticals’ (NASDAQ:ADMS) supplemental marketing application seeking approval to use Gocovri (amantadine) to treat OFF episodes in Parkinson’s disease (PD) patients receiving levodopa-based therapy. The agency’s action date is February 1, 2021.

The dopamine promoter was first approved in the U.S. in August 2017 for the treatment of dyskinesia (uncontrolled movements) in PD patients receiving levodopa-based therapy with or without concomitant dopaminergic medications.

https://seekingalpha.com/news/3580632-fda-accepts-adamas-application-for-expanded-use-of-gocovri