Treats uncomplicated urinary tract infections (acute cystitis). ANDA 210426, held by Novitium Pharma. Fosfomycin Tromethamine.
As of Nov 15, 2026, ANDA 210426 (Fosfomycin Tromethamine), held by Novitium Pharma, was first approved by FDA on Aug 12, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Fosfomycin Tromethamine Granules for Oral Solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine Granules for Oral Solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES section).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 12, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fosfomycin TromethamineEQ 3GM BASE/PACKET · for solution;oral | Fosfomycin Tromethamine | Rx |
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
