Amneal Pharmaceuticals, Inc. has announced that it received approval for its Abbreviated New Drug Application (“ANDA”) from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension. This medication, which combines ciprofloxacin, an antibacterial agent, with dexamethasone, a corticosteroid, is intended for treating infections caused by susceptible microorganisms in Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients, attributed to staphylococcus aureus and pseudomonas aeruginosa.

Andy Boyer, Executive Vice President and Chief Commercial Officer - Generics, stated, “This approval signifies the addition of another complex, high-value medication to our portfolio. It demonstrates the ongoing transition of our leading affordable medicines portfolio towards complex products and our continued successful business diversification.”

The most commonly reported adverse reactions associated with ciprofloxacin and dexamethasone otic suspension were ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%). For comprehensive prescribing information, please refer to the package insert.

Source: businesswire.com