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Your search for proton pump inhibitor returned 12 results

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Vonoprazan NDA Submitted for Erosive Esophagitis

The application is supported by data from the pivotal phase 3 PHALCON-EE trial which compared the efficacy and safety of vonoprazan to lansoprazole in patients with erosive esophagitis.
Drugs in the Pipeline

Novel H. pylori Eradication Therapy Effective in Phase 3 Trial

The ERADICATE Hp2 trial enrolled 455 dyspepsia patients at 55 sites across the US and randomized them to receive 4 capsules, 3 times daily, of either Talicia or the active comparator (amoxicillin 250mg and omeprazole 10mg), for a period of 14 days.
Drugs in the Pipeline

FDA Issues Complete Response Letter for Yosprala

The Food and Drug Administration (FDA) has issued a second Complete Response Letter (CRL) in response to the New Drug Application (NDA) for Yosprala (aspirin and omeprazole delayed-release tablets) 81/40 and 325/40.
Drugs in the Pipeline

FDA Accepts NDA Resubmission for PA32540/PA8140

The FDA has accepted for review Pozen's resubmitted New Drug Application (NDA) for aspirin and omeprazole (PA32540/PA8140) delayed-release tablets.
Drugs in the Pipeline

POZEN to Address CRL Issued for PA32540/PA8140

The FDA has issued a Complete Response Letter (CRL) to POZEN's New Drug Application (NDA) for aspirin and omeprazole (PA32540/PA8140) delayed-release tablets.
Drugs in the Pipeline

FDA Accepts Aciphex Pediatric NDA for Priority Review

Eisai announced that the FDA has accepted for priority review its New Drug Application (NDA) for Aciphex (rabeprazole sodium) delayed-release sprinkle capsules 5mg and 10mg for the proposed indication of healing of gastroesophageal reflux disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children 1-11 years of age.