Amneal Pharmaceuticals Inc. (AMRX) said it has received Abbreviated New Drug Application approval from the U.S. Food and Drug Administration for ciprofloxacin and dexamethasone otic suspension.
The product is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, and is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa.
The most common adverse reactions reported with ciprofloxacin and dexamethasone otic suspension were ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%).
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