FDA Refuses Acorda’s Inbrija New Drug Application Due to Manufacturing Questions
The U.S. Food and Drug Administration (FDA) will not process Acorda Therapeutics‘ marketing application for Inbrija (CVT-301), intended for the treatment of off-periods in Parkinson’s disease, until certain questions are answered. The FDA’s refusal to accept Acorda’s new drug application (NDA) for Inbrija wasn’t based on safety or efficacy concerns,…