FROM THE FOOD AND DRUG ADMINISTRATION
The Food and Drug Administration approved the first generic formulation of esomeprazole magnesium delayed-release capsules, the agency announced Jan. 26.
The new generic formulation of Nexium is approved to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older, according to the FDA statement announcing the approval. Ivax Pharmaceuticals manufactures generic esomeprazole in 20-mg and 40-mg capsules.
Like Nexium, generic esomeprazole is also approved to reduce the risk of gastric ulcers associated with use of NSAIDs, eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence, and treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Prescriptions for generic esomeprazole will be dispensed with a medication guide, which provides patients with information about esomeprazole’s uses and risks, including diarrhea and bone fractures. Nexium prescriptions also come with a medication guide.
Ivax is a subsidiary of Teva Pharmaceuticals USA.
