Movement Disorders

First Generic Version of Emflaza Oral Suspension Now Available for DMD

Diana Ernst, RPh
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Publish Date
The generic product labeling only includes information for DMD patients 5 years of age and older.

The Food and Drug Administration has approved the first generic version of Emflaza® (deflazacort) oral suspension for the treatment of Duchenne muscular dystrophy (DMD). 

Deflazacort is a corticosteroid prodrug that acts through the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects. The approval of the drug for DMD was established in a randomized, double-blind, placebo-controlled trial that included 196 male patients 5 to 15 years of age with confirmed DMD. Findings showed treatment with deflazacort led to significantly greater improvement in average muscle strength score compared with placebo.

The generic product is being made available by Cranbury Pharmaceuticals. The oral suspension (22.75mg/mL) is supplied as 13mL in a 30mL bottle packaged with 1 press-in bottle adapter and two 1mL oral dispensers. 

Deflazacort oral suspension is indicated for DMD patients 5 years of age and older. While Emflaza oral suspension is approved for children 2 to 5 years of age, due to PTC Therapeutics marketing exclusivity rights, the generic product is not labeled with that information.

This article originally appeared on MPR

References:
  1. Cranbury Pharmaceuticals receives US FDA approval for first generic version of Emflaza® oral suspension (deflazacort) for Duchenne muscular dystrophy. News release. Cranbury Pharmaceuticals. June 12, 2024. https://www.businesswire.com/news/home/20240612695808/en/Cranbury-Pharmaceuticals-Receives-U.S.-FDA-Approval-for-First-Generic-Version-of-Emflaza%C2%AE-Oral-Suspension-deflazacort-for-Duchenne-Muscular-Dystrophy.
  2. Deflazacort oral suspension. Package insert. Cranbury Pharmaceuticals;2024. Accessed June 12, 2024. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=881785a5-41b4-4679-a29b-5d77ca51ca60&type=display#section-11.1.