Posted by Michael Wonder on 14 Sep 2018
Acorda announces FDA extends Inbrija NDA review period
13 September 2018 - New PDUFA date of 5 January 2019.
Acorda Therapeutics today announced that the U.S. FDA has extended the Prescription Drug User Fee Act goal date for its review of the new drug application of Inbrija (levodopa inhalation powder) from 5 October 2018 to 5 January 2019.
This extension is related to recent submissions Acorda made in response to requests from FDA for additional information on chemistry, manufacturing and controls. FDA determined that these submissions constitute a major amendment and will take additional time to review.
