
USFDA6 Oct 2025, 03:08 pm
Zydus Lifesciences Receives Final USFDA Approval for Deflazacort Oral Suspension
AI Summary
Zydus Lifesciences Ltd. has announced that it has received final approval from the USFDA for Deflazacort oral suspension, 22.75 mg/mL. The oral suspension is indicated for treating Duchenne Muscular Dystrophy (DMD) in patients 5 years of age and older. Deflazacort belongs to a group of medications called steroids and works by decreasing inflammation and slowing down an overactive immune system. The product will be manufactured at Doppel, Italy. Zydus now has 424 approvals and has filed 487 ANDAs since the commencement of the filing process in FY 2003-04.
Key Highlights
- Zydus Lifesciences receives final approval from USFDA for Deflazacort oral suspension, 22.75 mg/mL
- Indicated for treating Duchenne Muscular Dystrophy (DMD) in patients 5 years of age and older
- Deflazacort oral suspension will be produced at Doppel, Italy
- Zydus has received 424 approvals and has filed 487 ANDAs since FY 2003-04