Treats Helicobacter pylori infection. NDA 213004, held by Talicia Holdings. Amoxicillin; Omeprazole Magnesium; Rifabutin.
As of Nov 13, 2026, NDA 213004 (Talicia), held by Talicia Holdings, was first approved by FDA on Nov 1, 2019, with 6 approved supplements and 0 published complete response letters.
TALICIA is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of TALICIA and other antibacterial drugs, TALICIA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Helicobacter pylori Infection
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 1, 2019 | Original applicationNew combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Talicia250MG;EQ 10MG BASE;12.5MG · capsule, delayed release;oral | Amoxicillin; Omeprazole Magnesium; Rifabutin | RxReference drug |
| May 1, 2024 | Supplement 14Labeling · Standard review | Approved | |
| Sep 8, 2023 | Supplement 10Labeling · Standard review | Approved | |
| Jul 18, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Mar 4, 2022 | Supplement 7Labeling · Standard review | Approved | |
| Oct 1, 2021 | Supplement 4Labeling · Standard review | Approved | |
| Nov 27, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Nov 1, 2019 | Original applicationNew combination · Priority 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
