Posted by Michael Wonder on 04 Jun 2020
Adamas announces FDA filing acceptance of sNDA to modify the indication statement for Gocovri to include treatment for Parkinson’s disease patients receiving levodopa and experiencing OFF episodes
4 June 2020 - Adamas Pharmaceuticals today announced that its supplemental new drug application for Gocovri as a treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy has been accepted for review by the U.S. FDA.
The anticipated Prescription Drug User Fee Act action date is 1 February 2021.
