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
NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity
Akums bridges the long-standing gap between paediatric syrups and conventional tablet formats
TFOS is indicated for the treatment of pulmonary arterial hypertension
Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex for the treatment of subependymal giant cell astrocytoma
The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen
Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation
This new medication eliminates the need for cold storage, making it more accessible and affordable for SCD patients across India
The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million
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