Acorda Therapeutics announced the resubmission of its New Drug Application (NDA) for INBRIJA to the U.S. Food and Drug Administration (FDA). INBRIJA is an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
The resubmission addressed the two issues raised in the recent Refusal to File (RTF) letter and included all additional information requested by the FDA in that letter.
The INBRIJA NDA is being submitted as a 505(b)(2) application. FDA is expected to inform Acorda within 74 days if the submission has been deemed complete and permits a full review.