FDA approves first generic version of Nexium tabs

SILVER SPRING, Md. — The Food and Drug Administration on Monday announced approval for the first generic version of Nexium (esomeprazole magnesium delayed-release capsules), which are used to treat gastroesophageal reflux disease in adults and children ages 1 year and older. The drug is a proton-pump inhibitor that reduces the amount of acid present in the stomach.

Ivax Pharmaceuticals, a subsidiary of Teva Pharmaceuticals, has gained approval to market the tablets in 20- and 40-milligram capsules. 

“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “It is important for patients to have access to treatment options for chronic conditions.”

Gastroesophageal reflux (GER) happens when stomach contents come back up into the esophagus, the FDA explained. Stomach acid that comes in contact with the esophagus can lead to acid indigestion. GERD is a chronic form of GER. Over time, GERD can lead to serious health problems.