Home / Drugs / Deflazacort Oral

Deflazacort Oral

FDA Drug Profile — Deflazacort Oral Suspension

Drug Details

Generic Name
Deflazacort Oral
Brand Names
Deflazacort Oral Suspension
Application Number
ANDA217813
Sponsor
Cranbury Pharmaceuticals, LLC
NDC Codes
2
Dosage Forms
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 )