FDA Accepts New Drug Application Filing for Edaravone to Treat ALS

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Mitsubishi Tanabe Pharma Corporation has announced that the FDA accepted the company’s New Drug Application for edaravone (MCI-186) which is an intravenous treatment for ALS. Based on the Prescription Drug User Fee Act, a decision is expected to be made on the application on June 16, 2017. Approval on the application would allow the medicine to be commercialized under the brand name RADICAVA through the newly-formed MT Pharama, Inc. Read the entire press release on the New Drug Application here.