Amneal Pharmaceuticals, Inc. announced it has received Abbreviated New Drug Application (?ANDA?) approval from the U.S. Food and Drug Administration (?FDA?) for ciprofloxacin and dexamethasone otic suspension. This 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.
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- Amneal Pharmaceuticals, Inc Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension