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Emflaza Approval History

FDA Approved: Yes (First approved February 9, 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 indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

Development History and FDA Approval Process for Emflaza

DateArticle
Jun  7, 2019Approval PTC Therapeutics Receives FDA Approval for the Expansion of the Emflaza (deflazacort) Labeling to Include Patients 2-5 Years of Age
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

Further information

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