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Talicia FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 28, 2023.

FDA Approved: Yes (First approved November 4, 2019)
Brand name: Talicia
Generic name: amoxicillin, omeprazole and rifabutin
Dosage form: Delayed-Release Capsules
Company: RedHill Biopharma Ltd.
Treatment for: Helicobacter Pylori Infection

Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a fixed-dose combination of two antibiotics, (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole) for the treatment of Helicobacter pylori (H. pylori) infection.

Development timeline for Talicia

DateArticle
Sep 18, 2023Approval RedHill Announces FDA sNDA Approval for Simplified Dosage Regimen for Talicia
Nov  4, 2019Approval FDA Approves Talicia (omeprazole magnesium, amoxicillin and rifabutin) for the Treatment of H. pylori Infection in Adults
Jul  3, 2019RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia
May  7, 2019RedHill Biopharma Submits New Drug Application for Talicia for H. pylori Infection
Dec  3, 2018RedHill Announces Positive Top-Line Results from Confirmatory Phase 3 Study with Talicia for H. pylori Infection

Further information

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