Results of NDA submission for Zegerid 40 mg (omeprazole immediate release suspension) for prevention of Upper GI bleeding related to stress ulcers.
IMPORTANT – IMPORTANT: According to FDA policies, when a company is attempting to obtain a new indication (e.g. Prevention of upper GI bleeding from stress-related mucosal damage – stress ulcers), the comparison must be to an FDA approved product for that indication. The only product that had been approved to prevent upper GI bleeding from stress ulceration when this study was started was continuous infusion intravenous cimetidine (300mg loading dose and 1200 mg per day).
Some may ask, “Why not i.v. Ranitidine or i.v. Famotidine or i.v. Pantoprazole or i.v. Lansoprazole – THE SIMPLE ANSWER IS THAT NONE OF THOSE AGENTS ARE APPROVED BY THE FDA.
