deflazacort

FDA Drug Profile — EMFLAZA, DEFLAZACORT, PYQUVI, Deflazacort

Drug Details

Generic Name
deflazacort
Brand Names
EMFLAZA, DEFLAZACORT, PYQUVI, Deflazacort
Application Number
NDA208684
Sponsor
PTC Therapeutics, Inc.
NDC Codes
10
Dosage Forms
TABLET, SUSPENSION
Routes
ORAL
Active Ingredients
DEFLAZACORT

Indications and Usage

1 INDICATIONS AND USAGE JAYTHARI is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza™ (deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. JAYTHARI is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older ( 1 )