FDA approves first generic version of Nexium

By Reuters Staff

(Reuters) - The U.S. Food and Drug Administration has approved the first generic version of AstraZeneca's proton pump inhibitor Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older.

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. It is important for patients to have access to treatment options for chronic conditions," Dr. Kathleen Uhl, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, said in a statement.

Generic esomeprazole capsules will be dispensed with a patient Medication Guide that provides 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 proton pump inhibitors 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

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.