The U.S. Food and Drug Administration has approved Iterum Therapeutics' oral antibiotic to treat a type of urinary tract infection in adult women, the health regulator said.

The drug has been approved to treat uncomplicated urinary tract infections (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.