SEPTEMBER 21, 2023

FDA Approves sDNA to Extend H. pylori Drug Dosing to New Regimen

The FDA has approved a supplemental new drug application for the omeprazole/amoxicillin/rifabutin combination drug Talicia (Redhill Biopharma), used for H. pylori eradication, to be taken in a new dosing regimen of at least four hours apart with food. 

The change allows for patients to follow a convenient “breakfast, lunch and dinner” routine, as opposed to the previously approved dosing regimen requiring dosing every eight hours with food. Currently, the combination drug is the