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Radicava Approval History

  • FDA approved: Yes (First approved May 5th, 2017)
  • Brand name: Radicava
  • Generic name: edaravone
  • Dosage form: Injection
  • Company: Mitsubishi Tanabe Pharma
  • Treatment for: Amyotrophic Lateral Sclerosis

Radicava (edaravone) is a free radical scavenger that relieves the effects of oxidative stress, a likely factor in the onset and progression of amyotrophic lateral sclerosis.

Development History and FDA Approval Process for Radicava

May  5, 2017Approval FDA Approves Radicava (edaravone) to Treat Amyotrophic Lateral Sclerosis (ALS)
Aug 30, 2016FDA Accepts Mitsubishi Tanabe Pharma's NDA Filing for Edaravone to Treat ALS
Jun 22, 2016Mitsubishi Tanabe Pharma Submits New Drug Application for Edaravone to Treat ALS in the United States

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