The U.S. Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.

Acute otitis externa is an infection in the outer ear and ear canal, usually caused by bacteria in the ear canal. Activities in which the ear is underwater can create a moist environment where bacteria may sometimes grow. The infection causes inflammation of the ear canal leading to pain, swelling, redness of the ear and discharge from the ear. 

Xtoro is an eardrop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus. Xtoro is the newest drug belonging to the fluoroquinolone antimicrobial drug class to be approved by the FDA. It joins several other antibacterial drug products previously approved to treat ear infections.

“The availability of multiple treatment options allows physicians and patients to find the treatment to meet their needs,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427274.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery