FDA Approves Generic Form of Nexium
TUESDAY, Jan. 27, 2015 (HealthDay News) -- The first generic version of Nexium (esomeprazole magnesium delayed-release capsules) has been approved by the U.S. Food and Drug Administration to treat gastroesophageal reflux disease in adults and children ages 1 and older.
Esomeprazole also is approved to reduce the likelihood of gastric ulcers associated with nonsteroidal anti-inflammatory drugs, the agency said. It is also approved to treat Helicobacter pylori along with certain antibiotics, and to treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome.
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. License to produce generic esomeprazole in 20 and 40 mg capsules was granted to Ivax Pharmaceuticals, a subsidiary of the Israeli firm Teva Pharmaceuticals.
