FDA Approves First Generic Version Of Esomeprazole For GERD Patients

First Posted: Jan 28, 2015 02:39 PM EST
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The U.S. Food and Drug Administration (FDA) has just approved the first generic version of Nexium--esomeprazole magnesium delayed-release capsules.

The drug has been approved to treat gastroesophageal reflux disease (GERD) in children age 1 or older and adults by the company Ivax Pharmaceuticals, Inc. They are working on two variants of 20 and 40 milligram capsules. 

Sixty percent of the adult population is estimated to suffer from some type of GERD, with symptoms ranging from heartburn to difficulty swallowing, dry cough, sore throat and regurgitation of food or sour liquid.

"It is important for patients to have access to treatment options for chronic conditions," said director of the Office of Generic Drugs, Kathleen Uhl, M.D., via SMN Weekly.

The capsulses have also been approved to treat low-grade gastric ulcer risk via a nonsteroial, inflammatory drug.

Adverse effects of the generic esomeprazole capsules include severe diarrhea, nausea, constipation, flatulence, sleepiness, dry mouth, abdominal pain and headache. Those who are also receiving daily doses of PPIs over an extended period of time are at increased risk of developing bone fracture and potential adverse stomach side effects. 

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