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Emflaza Approval History

  • FDA approved: Yes (First approved February 9th, 2017)
  • Brand name: Emflaza
  • Generic name: deflazacort
  • Dosage form: Tablets and Oral Suspension
  • Company: PTC Therapeutics, Inc.
  • Treatment for: Duchenne Muscular Dystrophy

Emflaza (deflazacort) is a glucocorticoid for the treatment of Duchenne Muscular Dystrophy.

Development History and FDA Approval Process for Emflaza

Apr 20, 2017PTC Therapeutics Completes Acquisition of Emflaza for the Treatment of Duchenne Muscular Dystrophy in the U.S.
Feb  9, 2017Approval FDA Approves Emflaza (deflazacort) to treat Duchenne Muscular Dystrophy
Aug 10, 2016FDA Accepts Marathon Pharmaceuticals’ NDA for Deflazacort for the Treatment of Duchenne Muscular Dystrophy
Jun 14, 2016Marathon Pharmaceuticals Announces Submission of Deflazacort New Drug Application to the FDA
Aug  5, 2015Marathon Pharmaceuticals to Begin NDA Process for Deflazacort as a Potential Treatment for Patients with Duchenne Muscular Dystrophy
Jan 19, 2015Marathon Pharmaceuticals Receives FDA Fast Track Designation for Deflazacort as a Potential Treatment for Duchenne Muscular Dystrophy

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