deflazacort

FDA Drug Profile — Deflazacort, DEFLAZACORT, EMFLAZA, PYQUVI

deflazacort is listed in the FDA National Drug Code directory with 10 NDC codes, marketed under brand names including Deflazacort, DEFLAZACORT, EMFLAZA. Available dosage forms: tablet, suspension.

Drug Details

Generic Name
deflazacort
Brand Names
Deflazacort, DEFLAZACORT, EMFLAZA, PYQUVI
Application Number
ANDA217173
Sponsor
Amneal Pharmaceuticals NY LLC
NDC Codes
10
Dosage Forms
TABLET, SUSPENSION
Routes
ORAL
Active Ingredients
DEFLAZACORT

Indications and Usage

1 INDICATIONS AND USAGE Deflazacort oral suspension 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) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information . Deflazacort oral suspension is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older ( 1 )