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FDA Approves Utility Therapeutics’ Pivya in UTIs

Clinical trial shows 62% of the 137 subjects achieved the composite response compared to 10% who received placebo.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Utility Therapeutics received approval from the U.S. FDA for Pivya (pivmecillinam) 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.    Uncomplicated UTIs are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract.    Pivya’s efficacy in treating females 18 years of age or older with uncomplicated U...

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