FDA Approves First Generic Version of GERD Drug Esomeprazole

The Food and Drug Administration Jan. 26 said it approved the first generic version of AstraZeneca’s heartburn drug Nexium (esomeprazole magnesium delayed-release capsules).

Ivax Pharmaceuticals Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 mg and 40 mg capsules, the FDA said. Nexium, which is made by AstraZeneca, is a proton pump inhibitor that reduces the amount of acid in the stomach.

Esomeprazole capsules are approved to treat gastroesophageal reflux disease (GERD) in adults and children ages one and older, to reduce the risk of gastric ulcers associated with use of nonsteroidal anti-inflammatory drugs ...