Drug Approval | October 07, 2025
FDA approves Zydus’ Deflazacort oral suspension, 22.75 mg/mL
Deflazacort oral suspension is indicated for treating Duchenne Muscular Dystrophy in patients 5 years of age and older
Deflazacort oral suspension is indicated for treating Duchenne Muscular Dystrophy in patients 5 years of age and older
The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India
Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg
The facility has been classified as Voluntary Action Indicated
The inspection concluded with zero form 483 observations
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
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