FDA Approves Treatment for Uncomplicated UTIs

The medication, Pivya, is now an option for women with uncomplicated urinary tract infections.

The Food and Drug Administration (FDA) approved Pivya tablets for treating uncomplicated urinary tract infections (UTIs) in adult females caused by certain bacteria.

“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” said Director Peter Kim of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Pivya will provide an additional treatment option for uncomplicated UTIs.”

The approval comes after three clinical trials that measured the efficacy and composite response. Pivya received Priority Review and Qualified Infectious Disease Product designations.

As the Lord Leads, Pray with Us…

  • For Director Kim to receive God’s guidance as he heads the Division of Anti-Infectives.
  • For discernment for Director Patrizia Cavazzoni as she oversees the Center for Drug Evaluation and Research.

Sources: Food and Drug Administration


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