Zydus Lifesciences gets USFDA nod for Deflazacort oral suspension
Zydus Lifesciences Ltd received final USFDA approval for its generic Deflazacort oral suspension (22.75 mg/ml) on Monday. This medication treats Duchenne Muscular Dystrophy (DMD) in patients aged five and older by decreasing inflammation. The comp...
By PTI |
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.
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.
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