Authors: Sharon Salt, Editor
In this week’s industry news round-up we set the focus on updates from the US FDA, as well as the halt of an Alzheimer’s drug following reports of a toxic reaction. Find out more below about our selection of the highlights this week:
Our pick of the headlines include:
Acorda Therapeutics announced FDA extension of Inbrija™ review
Acorda Therapeutics (NY, USA) has announced that the FDA has extended the Prescription Drug User Fee Act goal date for its review of the New Drug Application of Inbrija™ (levodopa inhalation powder) to January 2019.
This extension is related to a recent submission Acorda made in response to requests from the FDA for additional information on chemistry, manufacturing and controls. The FDA has determined that these submissions constitute a major amendment and will take additional time to review.
“We look forward to continuing our constructive dialogue with FDA,” commented Ron Cohen, President and CEO of Acorda. “We remain committed to bringing Inbrija to approval for people with Parkinson’s who experience OFF periods, which are highly disruptive and in need of new therapeutic options.”