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Talicia Approval Status

FDA Approved: No
Brand name: Talicia
Generic name: amoxicillin, omeprazole and rifabutin
Dosage form: Capsules
Company: RedHill Biopharma Ltd.
Treatment for: Helicobacter Pylori Infection

Talicia (RHB-105) is a fixed-dose combination of two antibiotics, rifabutin, and amoxicillin, and a proton pump inhibitor (PPI), omeprazole, in development for the treatment of Helicobacter pylori infection.

Development Status and FDA Approval Process for Talicia

DateArticle
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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