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news.AstraZeneca has submitted a supplemental new drug application to the FDA for Nexium IV for injection to seek approval for use in patients with peptic ulcer bleeding following therapeutic endoscopy.
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Nexium IV for Injection is indicated for the short-term treatment of gastroesophageal reflux disease adult patients with a history of erosive esophagitis, as an alternative to oral therapy in patients when therapy with Nexium (esomeprazole magnesium) delayed-release capsules is not possible or appropriate.
The regulatory submission incorporates data from the Nexium IV peptic ulcer bleed study, a multinational, randomized trial of 767 patients with peptic ulcer bleeding (PUB). To date, there is no proton pump inhibitor therapy globally approved for this indication.