FDA accepts Mitsubishi Tanabe Pharma’s NDA filing for edaravone to treat ALS

30 August 2016 - Edaravone may be the first ALS treatment approved in U.S. in more than 20 years.

Mitsubishi Tanabe Pharma Corporation today announced that the U.S. FDA has accepted the company’s new drug application for edaravone (MCI-186) an intravenous treatment for amyotrophic lateral sclerosis (ALS), a rapidly progressive neurological disease. A decision on the application is anticipated on June 16, 2017 based on the Prescription Drug User Fee Act. If approved, the medicine will be commercialized, under the brand name Radicava, through the newly-formed MT Pharma America, Inc.

Read Mitusbishi Tanabe press release

Michael Wonder

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Michael Wonder

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Medicine , US , Submission