FDA approves first generic esomeprazole

FDA

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.”

For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431648.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Michael Wonder

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Michael Wonder

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