Teva Gets FDA OK for Generic Esomeprazole

The US Food and Drug Administration has approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages one and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.

Teva Pharmaceutical Industries gained approval to market esomeprazole in 20 and 40 milligram capsules. Esomeprazole capsules are also approved to reduce the risk of gastric ulcers associated with use of nonsteroidal anti-inflammatory drugs (NSAIDs), treat the stomach infection Helicobacter pylori along with certain antibiotics, and to treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome.

Esomeprazole is the active ingredient in AstraZeneca’s Nexium, one of the company’s top-selling drugs. Nexium delayed-release capsules, marketed by AstraZeneca, had annual sales of approximately $6 billion in the United States, according to IMS data as of November 2014 and as reported by Teva.

Source: FDA and Teva

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