The US Food and Drug Administration (FDA) has approved the first generic version of AstraZeneca's proton pump inhibitor Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older.
Ivax Pharmaceuticals, Inc, a subsidiary of Teva Pharmaceuticals USA, will market esomeprazole in 20- and 40-mg capsules.
Esomeprazole capsules are also approved to reduce the risk for gastric ulcers associated with nonsteroidal anti-inflammatory drugs, treat Helicobacter pylori infection along with certain antibiotics, and treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome, the FDA notes.
Generic esomeprazole capsules will come with a patient medication guide that provides information about the medication's use and risks. The most serious risks are stomach problems, including severe diarrhea. The guide also notes that people who take multiple daily doses of proton pump inhibitors for long periods may have an increased risk for bone fractures.
The most common adverse effects reported by those taking Nexium in clinical trials include headache, diarrhea, nausea, flatulence, abdominal pain, sleepiness, constipation, and dry mouth.
"It is important for patients to have access to treatment options for chronic conditions. Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards," Kathleen Uhl, MD, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, said in a statement.
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Cite this: FDA Clears First Generic Esomeprazole for GERD - Medscape - Jan 26, 2015.
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