Alembic Pharma Bags USFDA Approval for USD 110 Million Generic Ear Infection Drug
New Delhi: Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its generic Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3%/0.1%, strengthening its presence in the US pharmaceutical market.
The company received approval for its Abbreviated New Drug Application (ANDA), which is therapeutically equivalent to Ciprodex Otic Suspension, 0.3%/0.1%, the reference listed drug marketed by Sandoz Inc.
The approved medication is indicated for treating certain ear infections caused by susceptible bacterial strains. Its approved uses include acute otitis media in paediatric patients aged six months and older who have tympanostomy tubes, and acute otitis externa in paediatric patients aged six months and older, adults and elderly patients.
According to IQVIA data cited by the company, the US market for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3%/0.1%, was estimated at US$110 million for the 12 months ended June 2026.
The approval adds another product to Alembic Pharmaceuticals’ portfolio of generic medicines for the US market, where regulatory clearances play an important role in expanding product offerings and commercial opportunities.
With the latest clearance, Alembic Pharmaceuticals has secured a cumulative 246 ANDA approvals from the USFDA, comprising 226 final approvals and 20 tentative approvals.
The latest approval further strengthens Alembic Pharmaceuticals’ position in the US generics market and expands its range of products targeting established therapeutic segments.
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