Oct 25 (Reuters) - The U.S. Food and Drug Administration

has approved Iterum Therapeutics' ( ITRM ) oral antibiotic to

treat a type of urinary tract infection (UTI) in adult women,

the health regulator said on Friday.

The drug has been approved to treat uncomplicated UTIs, a

common bacterial infection of the bladder that mostly affects

women with normal anatomy of the urinary tract.

Half of all women in the U.S. experience at least one

uncomplicated UTI during their lifetime, according to the

company. Despite the approval of several antibiotics, some

patients may have limited options due to side effects and a rise

in drug-resistant bacteria.

The regulator's decision comes after it declined to approve

the drug in 2021, calling for more data. The company

subsequently re-submitted its application after late-stage

trials showed the drug was well-tolerated with no safety issues

identified.