FDA extends PDUFA date for Inbrija to treat Parkinsons.- Acorda Therapeutics

Acorda Therapeutics, Inc. announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Inbrija (levodopa inhalation powder) from 5 October 2018 to 5 January 5 2019.

This extension is related to recent submissions Acorda made in response to requests from FDA for additional information on chemistry, manufacturing and controls (CMC). FDA determined that these submissions constitute a major amendment and will take additional time to review.