Treats acute intestinal amebiasis (amoebic dysentery) and amebic liver abscess. NDA 216755, held by Saptalis Pharms. Metronidazole.
As of Nov 13, 2026, NDA 216755 (Likmez), held by Saptalis Pharms, was first approved by FDA on Sep 22, 2023, with 3 approved supplements and 0 published complete response letters.
LIKMEZ is a nitroimidazole antimicrobial indicated for Trichomoniasis in adults Amebiasis in adults and pediatric patients Anaerobic Bacterial Infections in adults To reduce the development of drug-resistant bacteria and maintain the effectiveness of LIKMEZ and other antibacterial drugs, LIKMEZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Trichomoniasis LIKMEZ is indicated for the treatment of: Symptomatic trichomoniasis caused by Trichomonas vaginalis in adult females and males when the diagnosis is confirmed by appropriate laboratory procedures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 22, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Likmez500MG/5ML · suspension;oral | Metronidazole | RxReference drug |
| Feb 28, 2025 | Supplement 4Labeling · Standard review | Approved | |
| Jul 8, 2024 | Supplement 3Labeling · Standard review | Approved | |
| May 14, 2024 | Supplement 1Labeling · Standard review | Approved | |
| Sep 22, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
