FDA approves first generic esomeprazole

The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.

Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole 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."

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.

Gastroesophageal reflux (GER) happens when stomach contents come back up into the esophagus. Stomach acid that touches the lining of the esophagus can cause acid indigestion (also called acid reflux or heartburn). GERD is a more serious, long-lasting (chronic) form of GER. GER that occurs more than twice a week for a few weeks could be GERD, which over time can lead to more serious health problems, such as inflammation of the esophagus (esophagitis) and respiratory problems.

Generic esomeprazole capsules will be dispensed with a patient Medication Guide that provides important information about the medication's use and risks. The most serious risks are stomach problems, including severe diarrhea, and a warning that people who take multiple daily doses of PPIs for a long period of time may have an increased risk of bone fractures.

The most common side effects reported by those taking Nexium in clinical trials include headache, diarrhea, nausea, flatulence, abdominal pain, sleepiness, constipation, and dry mouth.

Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.