Amneal Pharma Receives FDA Approval For Ciprofloxacin And Dexamethasone Otic Suspension

(RTTNews) - 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%).

For More Such Health News, visit rttnews.com.