RedHill Biopharma Ltd. announced the U.S. Food and Drug Administration's (FDA) approval of its supplemental new drug application (sNDA) for Talicia, allowing a change to a more flexible three times daily (TID), taken at least 4 hours apart with food, dosing regimen for H. pylori eradication. This differs from the previously approved dosing regimen (Q8H), which required dosing every eight hours with food, by enabling patients to follow a convenient "breakfast, lunch and dinner" dosing routine, which may support increased patient adherence and optimize the potential for successful H. pylori eradication.
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- Redhill Biopharma Ltd. Announces Fda Snda Approval for Talicia®?