By Dean Seal

Amneal Pharmaceuticals said the Food and Drug Administration has approved its abbreviated new drug application for ciprofloxacin and dexamethasone otic suspension, a combination used to treat infections.

The Bridgewater, N.J.-based company said the combination of ciprofloxacin and dexamethasone is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in acute otitis externa due to staphylococcus aureus and pseudomonas aeruginosa.

The most common adverse reactions reported with the combination were ear pain, ear discomfort and ear pruritus.

Write to Dean Seal at dean.seal@wsj.com


(END) Dow Jones Newswires

03-25-24 1639ET