Helicobacter pylori is a spiral-shaped gram-negative bacterium involved in the development of gastritis, duodenal and gastric ulcers, and gastric cancer.
Infection is strongly associated with the development of gastric epithelial and lymphoid malignancies.
Acute infection is mostly asymptomatic and is acquired through human-to-human contact via gastro-oral and fecal-oral routes.
Adaptability in gastric conditions and production of urease allow it to colonize the stomach.
New drug application approved by US FDA as of 01 - 15 September 2019 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.