Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Deflazacort oral suspension (Emflaza Oral Suspension, 22.75 mg/mL).
The product is indicated for treating Duchenne Muscular Dystrophy (DMD) in patients 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.
Zydus stated that its deflazacort oral suspension will be produced at Doppel, Italy.
Since the commencement of its filing process in FY 2003–04, the group has filed 487 ANDAs and has received 424 approvals so far.
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