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The Food and Drug Administration (FDA) announced the approval of the oral antibiotic pivmecillinam for treating uncomplicated urinary tract infections (UTIs) in women over age 18. Marketed as Pivya, pivmecillinam has a unique mechanism of action to treat UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. It’s been in use outside of the United States for decades, but it’s the first antibiotic for UTIs approved by FDA in 20 years. In a clinical trial, 62% of 137 participants who received pivmecillinam achieved composite response, compared to 10% of 134 who received placebo. 

More options for UTIs: According to CIDRAP, the 3 most commonly prescribed first-line antibiotics for uncomplicated UTIs—nitrofurantoin, sulfamethoxazole and trimethoprim, and fluoroquinolones—have been limited by resistance, efficacy, and safety issues. Pivmecillinam provides another option.

New Antibiotic Approved for UTIs