FDA Approves Generic Rabeprazole Delayed-Release for GERD

Troy Brown, RN

Disclosures

November 13, 2013

The US Food and Drug Administration (FDA) has approved the first generic versions of Aciphex (rabeprazole sodium; Eisai) delayed-release tablets for the treatment of gastroesophageal reflux disease (GERD) in adults and adolescents aged 12 years and older, according to an FDA statement.

Rabeprazole is a proton pump inhibitor that treats GERD symptoms including heartburn, acid regurgitation, and nausea by decreasing the amount of gastric acid produced in the stomach. This allows the esophagus to heal and prevents further damage. Rabeprazole is also used to treat conditions that cause the stomach to produce too much acid, such as Zollinger-Ellison syndrome.

"Health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigid standards of quality as the brand-name drug," Kathleen Uhl, MD, acting director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, said in the statement. "This medication is widely used by people who have gastroesophageal reflux disease, so it is important to have access to affordable treatment options."

The FDA has granted marketing approval for generic rabeprazole to Dr. Reddy's Laboratories Ltd, Kremers Urban Pharmaceuticals Inc, Lupin Pharmaceuticals Inc, Mylan Pharmaceuticals Inc, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd.

In clinical trials in adults, the most frequently reported adverse reactions were sore throat, flatulence, infection, and constipation. In clinical trials in adolescents, the most commonly reported adverse reactions were abdominal pain, diarrhea, and headache.

FDA-approved generic prescription drug manufacturing and packaging sites are required to pass the same quality standards as those required of brand-name drugs.

For more information about the availability of generic rabeprazole, contact the manufacturers.

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