Zydus Lifesciences wins USFDA nod for deflazacort suspension to treat DMD in children

Drugmaker Zydus Lifesciences Ltd on Monday (October 6) said it has received final approval from the United States Food and Drug Administration (USFDA) for deflazacort oral suspension, 22.75 mg/mL. The product is a generic version of Emflaza oral suspension, 22.75 mg/mL.

Deflazacort oral suspension is indicated for the treatment of Duchenne Muscular Dystrophy (DMD) in patients aged five years and older. The drug, belonging to the class of steroids, helps decrease inflammation and slow down an overactive immune system.

Zydus stated that the product will be manufactured at Doppel, Italy. With this approval, the group’s total tally of approvals now stands at 424. Since commencing its abbreviated new drug application (ANDA) filing process in FY 2003-04, Zydus has filed 487 ANDAs as of September 30, 2025.

Also Read: Zydus Life Q1 Results: FY26 guidance maintained but stock falls on subdued earnings

Last week, Zydus Lifesciences said its US subsidiary, Sentynl Therapeutics, Inc., has received a Complete Response Letter (CRL) from the US Food and Drug Administration (USFDA) regarding its New Drug Application (NDA) for copper histidinate (CUTX-101), a treatment for Menkes disease in pediatric patients.

In its letter, the USFDA outlined certain findings that need to be addressed before clarifying the path forward. The concerns relate specifically to a current Good Manufacturing Practices (CGMP) inspection of the facility where CUTX-101 is manufactured.

Zydus noted that it had recently submitted responses to the USFDA following a re-inspection in September 2025, proving the facility’s CGMP compliance, and is currently awaiting the Establishment Inspection Report (EIR).

Also Read: Zydus Lifesciences arm launches generic drugs for cats and dogs in US

Shares of Zydus Lifesciences Ltd ended at ₹994.55, up by ₹5.80, or 0.59%, on the BSE.