India Pharma Outlook Team | Tuesday, 07 October 2025
Zydus Lifesciences has received final clearance from the USFDA for its Deflazacort Oral Suspension (22.75 mg/mL) for the treatment of Duchenne Muscular Dystrophy in patients aged 5 years and older, which is a generic version of Emflaza Oral Suspension.
This is the second approval for Zydus aimed at increasing Zydus' foothold in the US generics market.
Deflazacort Oral Suspension is a corticosteroid that reduces inflammation and treats the overactive immune response that occurs in patients with DMD, also improving outcomes for patients. Zydus conveyed that the manufacturing of Deflazacort Oral Suspension will occur at its manufacturing facility (Doppel) in Italy.
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In total, this brings Zydus Lifesciences' total USFDA approvals to 424. Zydus Lifesciences and received clearance for 487 ANDAs as of September 30, 2025, since the company began their abbreviated new drug application (ANDA) process in FY 2003-04 which further signals their strong regulatory and manufacturing abilities within the global market.
Last week, Zydus also announced that its US subsidiary, Sentynl Therapeutics, Inc., received a Complete Response Letter (CRL) from the USFDA for its application for copper histidinate (CUTX-101), an investigational drug product indicated for Menkes disease in pediatric patients. The company has provided its compliance responses after a re-inspection in September 2025 and is awaiting the final Establishment Inspection Report (EIR) from the regulator.
