Zydus Lifesciences gets USFDA nod for Deflazacort oral suspension

New Delhi: Zydus Lifesciences Ltd on Monday said it has received final approval from the US health regulator for its generic version of Deflazacort oral suspension used in treating a severe form of inherited muscular dystrophy.

The approval by the US Food and Drug Administration (USFDA) is for Deflazacort oral suspension of strength 22.75 mg/ml, Zydus Lifesciences Ltd said in a regulatory filing.

Deflazacort oral suspension is indicated for treating Duchenne Muscular Dystrophy (DMD) in patients of five 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.

It will be produced at Doppel, Italy, the company said.