Acorda Receives Refusal to File Letter from FDA for INBRIJA™ (CVT-301, levodopa inhalation powder) New Drug Application
ARDSLEY, N.Y.–(BUSINESS WIRE[1])–Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) 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...