Pivya FDA Approval History
Last updated by Judith Stewart, BPharm on May 15, 2024.
FDA Approved: Yes (First approved April 24, 2024)
Brand name: Pivya
Generic name: pivmecillinam
Dosage form: Tablets
Company: Utility Therapeutics Ltd.
Treatment for: Urinary Tract Infection
Pivya (pivmecillinam) is a penicillin class antibacterial for use in the treatment of uncomplicated urinary tract infections.
- Pivya is indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Pivya and other antibacterial drugs, Pivya should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. - Uncomplicated UTIs are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract.
- Pivya contains pivmecillinam which is a pro-drug that is hydrolyzed to the active antibacterial agent mecillinam. Mecillinam is a beta-lactam antibacterial that is mainly active against gram-negative bacteria and works by interfering with the biosynthesis of the bacterial cell wall.
- Pivya tablets are administered orally three times a day for 3 to 7 days as clinically indicated.
- Warnings and precautions associated with Pivya include hypersensitivity reactions, severe cutaneous adverse reactions, carnitine depletion, and clostridioides difficile-associated diarrhea.
- Common adverse reactions include nausea and diarrhea.
Development timeline for Pivya
Date | Article |
---|---|
Apr 24, 2024 | Approval FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.