FDA approves Zydus’ Deflazacort oral suspension, 22.75 mg/mL

Deflazacort oral suspension is indicated for treating Duchenne Muscular Dystrophy in patients 5 years of age and older

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Deflazacort oral suspension (USRLD: Emflaza Oral Suspension, 22.75 mg/mL).

Deflazacort oral suspension is indicated for treating Duchenne Muscular Dystrophy (DMD) in patients 5 years of age and older. Deflazacort belongs to a group of medications called steroids. It works by decreasing inflammation and slowing down an overactive immune system. Deflazacort oral suspension will be produced at Doppel, Italy.

The group now has 424 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04.