MONDAY, Jan. 26, 2015 (HealthDay News) — The first generic version of the heartburn drug Nexium (esomeprazole) has been approved by the U.S. Food and Drug Administration.
The drug helps treat GERD, which stands for gastroesophageal reflux disease. GERD occurs when stomach acid backs into the esophagus, and is commonly known as chronic heartburn or acid reflux.
License to produce generic esomeprazole in 20 milligram and 40 milligram capsules was granted to Ivax Pharmaceuticals, a subsidiary of the Israeli firm Teva Pharmaceuticals, the FDA said in a news release.
Esomeprazole also is approved to reduce the likelihood of gastric ulcers associated with a class of painkillers known as non-steroidal anti-flammatory drugs (NSAIDs), the agency said. And it is approved to treat a stomach infection with H. pylori bacteria, which has been tied to ulcers.
A medication guide distributed with the drug warns of potential problems including severe diarrhea and, with extended use, the greater potential for bone fractures, the FDA said.
The most common side effects of esomeprazole include headache, diarrhea, nausea, flatulence, abdominal pain, fatigue, constipation and dry mouth.
The FDA stressed that approved generic drugs are of the same strength and quality as their brand-name equivalents.
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