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First Generic Versions of Delayed-Release Rabeprazole (AcipHex) Approved to Treat GERD

Six manufacturers get green light (November 8)

The FDA has approved the first generic versions of rabeprazole sodium delayed-release tablets (AcipHex, Eisai), used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (aged 12 years and older).

GERD, also called acid reflux or acid regurgitation, is a common condition in which backward flow of acid from the stomach causes heartburn and possible injury to the esophagus.

Dr. Reddy’s Laboratories, Kremers Urban Pharmaceuticals, Lupin Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals have all received FDA approval to market generic rabeprazole.

Rabeprazole, a proton-pump inhibitor, works by decreasing the amount of acid produced in the stomach, thereby treating the symptoms of GERD, such as heartburn, regurgitation of acid, and nausea.

Rabeprazole is also used to treat conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. In addition, the drug is used to treat gastrointestinal ulcers and is used in combination with other medications to eliminate Helicobacter pylori, a type of bacteria that causes ulcers.

In clinical trials of AcipHex in adults, the most common adverse reactions reported by those taking AcipHex were sore throat, flatulence, infection, and constipation. In studies of adolescents, the adverse reactions most frequently reported by those taking AcipHex were abdominal pain, diarrhea, and headache.

Source: FDA; November 8, 2013.

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