AstraZeneca Submits sNDA for Nexium I.V. for Peptic Ulcer Bleed Indication

AstraZeneca today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for NEXIUM(R) I.V. (esomeprazole sodium) for Injection to seek approval for use in patients with peptic ulcer bleeding (PUB) following therapeutic endoscopy. The regulatory submission incorporates data from the NEXIUM I.V. Peptic Ulcer Bleed study, a multinational, randomized trial of 767 patients with peptic ulcer bleeding (PUB). To date, there is no proton pump inhibitor (PPI) therapy globally approved for this indication. Presently, NEXIUM I.V. for Injection is indicated for the short-term treatment (up to 10 days) of GERD adult patients with a history of erosive esophagitis, as an alternative to oral therapy in patients when therapy with NEXIUM(R) (esomeprazole magnesium) Delayed-Release Capsules is not possible or appropriate.

The details can be read here.