FDA Refuses Acorda’s Inbrija New Drug Application Due to Manufacturing Questions

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, but was related to the drug candidate’s manufacturing process. In a ... read more
Source: Parkinson’s News TodayPublished on 2017-08-30By Magdalena Kegel