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Alembic Pharma Secures USFDA Approval for Generic Ear Infection Drug
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News18•19-10-2026, 15:30
Alembic Pharma Secures USFDA Approval for Generic Ear Infection Drug
- •Alembic Pharmaceuticals has received final approval from the USFDA for Ciprofloxacin and Dexamethasone Otic Suspension USP.
- •The medication is used to treat ear infections in pediatric patients aged six months and older, as well as adults and elderly patients.
- •The approved product is therapeutically equivalent to Sandoz Inc's Ciprodex Otic Suspension.
- •The drug targets conditions including Acute Otitis Media and Acute Otitis Externa.
- •The estimated market size for this drug in the US is USD 110 million for the 12 months ending June 2026.
Key Questions Answered
Alembic Pharmaceuticals received final USFDA approval for its generic Ciprofloxacin and Dexamethasone Otic Suspension USP, which is indicated for treating certain ear infections in adults and pediatric patients aged six months and older.
The approved Abbreviated New Drug Application is therapeutically equivalent to Sandoz Inc.'s reference listed drug product, Ciprodex Otic Suspension, 0.3 per cent/0.1 per cent.
With this clearance, Alembic has accumulated a total of 246 ANDA approvals from the US health regulator, which include 226 final approvals and 20 tentative approvals.
