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FDA Approves Generic Esomeprazole for GERD
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The FDA today approved the first generic esomeprazole capsules for the treatment of GERD in adults and children aged 1 year and older, according to an FDA news release.
This generic version of esomeprazole magnesium delayed-release capsules (Nexium, AstraZeneca) will be marketed by Ivax Pharmaceuticals in 20 mg and 40 mg capsules, according to the release. The medication will be dispensed with a patient guide with information about use and risks, the most serious of which are stomach problems including severe diarrhea, and a warning that people who take multiple daily doses of proton pump inhibitors long-term can have increased risk for bone fracture. Common side effects reported in clinical trials included headache, diarrhea, nausea, flatulence, abdominal pain, sleepiness, constipation and dry mouth, the release said.
“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 the release. “It is important for patients to have access to treatment options for chronic conditions.”
Esomeprazole is also approved to reduce risk for nonsteroidal anti-inflammatory drug-related gastric ulcer, to treat Helicobacter pylori infection in combination with antibiotics, and to treat conditions related to stomach acid overproduction such as Zollinger-Ellison syndrome, the release said.