Alembic Pharma wins US FDA nod for generic ear infection treatment

Alembic Pharmaceuticals Ltd announced on Monday that it has obtained final approval from the US Food and Drug Administration (USFDA) for its generic Ciprofloxacin and Dexamethasone Otic Suspension USP. The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug Ciprodex Otic Suspension produced by Sandoz Inc, the company said in a regulatory filing.

The medication is indicated for treatment of ear infections caused by susceptible microorganisms in multiple patient populations. These include Acute Otitis Media (AOM) in pediatric patients aged six months and older with tympanostomy tubes, and Acute Otitis Externa (AOE) in pediatric patients six months and older, as well as adult and elderly patients.

The approval expands Alembic's portfolio in the ophthalmic and otic therapeutic segment, allowing the company to serve the US market with a cost-effective generic alternative to the branded formulation. The generic version is expected to provide patients with increased treatment options at lower costs, consistent with the company's strategy to develop quality pharmaceutical products for global markets.

Alembic Pharmaceuticals, headquartered in Gujarat, is among India's leading pharmaceutical manufacturers with a strong presence across key therapeutic segments including antibiotics, anti-inflammatory drugs, and specialty pharmaceuticals.