FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections
The FDA approved Pivya tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
- Pivya’s efficacy in treating females 18 years of age or older with uncomplicated UTIs was assessed in three controlled clinical trials comparing different Pivya dosing regimens to placebo, ibuprofen and another oral antibacterial drug.
- Patients should not use Pivya if they have a known history of severe hypersensitivity to Pivya or other beta-lactam antibacterial drugs.
- The FDA granted the approval of Pivya to UTILITY Therapeutics Ltd.
Source: UTILITY Therapeutics Ltd.
