Amneal receives FDA approval for ciprofloxacin, dexamethasone otic suspension

Amneal Pharmaceuticals announced it has received Abbreviated New Drug Application approval from the U.S. Food and Drug Administration 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 in pediatric, adult, and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa. “This approval represents the addition of another complex, high value medicine,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Generics. “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.”