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7/22/2003

Ciprodex Approved for Treatment of Ear Infections

Kate Traynor

Alcon Inc. announced yesterday that it has received approval from the Food and Drug Administration (FDA) to market Ciprodex Otic, a topical suspension of ciprofloxacin and dexamethasone, for the treatment of acute otitis media in children age six months or older with tympanostomy tubes.

The combination product was also approved for the treatment of acute otitis externa, or swimmer's ear, in children six months or older and adults.

According to an Alcon press release, inflammation in the inner ear can prevent topically administered antimicrobial agents from reaching the site of infection. The antiinflammatory effects of dexamethasone in Ciprodex Otic presumably decrease swelling of the inner ear and increase the penetration of ciprofloxacin.

The FDA-approved labeling for Ciprodex Otic is not yet available. An Alcon spokeswoman said that the product contains ciprofloxacin 0.3 percent and dexamethasone 0.1 percent.

Ciprodex Otic was developed by Bayer AG and licensed to Alcon. Alcon expects the product to be available in pharmacies by the end of August.