RedHill Announces FDA sNDA Approval for Talicia®
Redhill Biopharma Ltd. - American Depositary Shares (RDHL)
US:NASDAQ Investor Relations:
ir.redhillbio.com/investor-relations
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Source: PR Newswire
FDA approves supplemental new drug application (sNDA) for Talicia, changing dosing to a simplified three times daily (TID) regimen, which may support increased patient adherence and treatment outcomesTalicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[1] for eradication of H. pylori - a bacterial infection that affects approximately 35% of the U.S. adult population[2]RALEIGH, N.C. and TEL-AVIV, Israel, Sept. 18, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the U.S. Food and Drug Administration's (FDA) approval of its supplemental new drug application (sNDA) for Talicia[3], 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
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