- The FDA approves the Abbreviated New Drug Application (ANDA) from Teva Pharmaceutical Industries (TEVA -1.8%) subsidiary Ivax Pharmaceuticals for a generic version of AstraZeneca's (AZN -0.2%) Nexium (esomeprazole magnesium delayed-release capsules). Esomeprazole is a proton pump inhibitor that reduces stomach acid.
- The primary indication is the treatment of gastroesophageal reflux disease (GERD) in adults and children at least one year old. It is also cleared for the reduction in risk of gastric ulcers associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), the treatment of stomach infection from Helicobactor pylori in conjunction with certain antibiotics and the treatment of conditions where the stomach produces excess acid, including Zollinger-Ellison syndrome.
- It is the first generic esomeprazole to gain regulatory clearance in the U.S.