Posted by Michael Wonder on 29 May 2018
Acorda announces EMA validation of the MAA submission for Inbrija (levodopa inhalation powder)
29 May 2018 - Acorda Therapeutics today announced that the EMA has completed formal validation of Acorda’s marketing authorisation application for Inbrija.
Inbrija is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.The Inbrija MAA was submitted to the EMA on 23 March 2018.
The U.S. FDA is currently reviewing a new drug application for Inbrija and has set an action date of 5 October 2018 under the Prescription Drug User Fee Act.
