Zydus Lifesciences has received final approval from the USFDA for Deflazacort oral suspension, 22.75 mg/mL. This medication is indicated for treating Duchenne Muscular Dystrophy (DMD) in patients 5 years and older. The oral suspension will be manufactured at Doppel, Italy. The company now has 424 approvals and has filed 487 ANDAs since fiscal year 2003-04.
USFDA Approval Received
Zydus Lifesciences Limited has been granted final approval from the United States Food and Drug Administration (USFDA) for Deflazacort oral suspension (USRLD: Emflaza Oral Suspension, 22.75 mg/mL), as announced on October 6, 2025.
Therapeutic Indication
Deflazacort oral suspension is prescribed for treating Duchenne Muscular Dystrophy (DMD) in patients aged 5 years and above. This medication functions by alleviating inflammation and regulating an overactive immune response.
Manufacturing Location
The production of Deflazacort oral suspension will take place at Doppel’s facilities in Italy.
Approval Portfolio
As of the current announcement, Zydus Lifesciences has secured a total of 424 approvals. The company has also filed 487 ANDAs since the commencement of its filing activities in FY 2003-04.
Source: BSE
