Treats uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of…. NDA 216483, held by Alembic Therap. Pivmecillinam Hydrochloride.
As of Nov 14, 2026, NDA 216483 (Pivya), held by Alembic Therap, was first approved by FDA on Apr 24, 2024, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE PIVYA is a penicillin class antibacterial 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 2024 | Original applicationNew active ingredient · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| PivyaEQ 185MG BASE · tablet;oral | Pivmecillinam Hydrochloride | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
