29 August 2017 - Acorda Therapeutics today announced that it received a refusal to file letter from the U.S. FDA regarding its new drug application for Inbrija. 

Inbrija is an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.

Upon its preliminary review, FDA determined that the NDA, submitted on 26 June 2017, was not sufficiently complete to permit a substantive review. FDA specified two reasons for the refusal to file (RTF): first, the date when the manufacturing site would be ready for inspection, and, second, a question regarding the submission of the drug master production record. FDA also requested additional information at resubmission, which was not part of the basis for the RTF.

Read Acorda Therapeutics press release