FDA approves Xtoro from Alcon Labs

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday approved Xtoro (finafloxacin otic suspension), a new drug that's used to treat acute otitis externa, commonly known as swimmer's ear. 

 

Acute otitis externa is an infection that occurs in the outer ear and ear canal; it's usually brought on by bacteria in the ear canal. Activities where the ear is underwater can create an environment where bacteria can sometimes grow. The infection leads to inflammation of the ear canal, resulting in pain and swelling as well as redness of the ear and discharge from the ear. 

 

“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. 

 

Xtoro is manufactured by Alcon Labs.