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FDA NEWS RELEASE

 
For Immediate Release: Nov. 8, 2013
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
 
 

FDA approves first generic versions of Aciphex delayed-release tablets to treat GERD

 
The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
 
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 (the tube that connects the throat and stomach).
 
Dr. Reddy’s Laboratories Ltd., Kremers Urban Pharmaceuticals Inc., Lupin Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic rabeprazole.
 
“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,” said Kathleen Uhl, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “This medication is widely used by people who have gastroesophageal reflux disease, so it is important to have access to affordable treatment options.”
 
Rabeprazole is in a class of medications called proton-pump inhibitors. The medication works by decreasing the amount of acid made in the stomach, treating the symptoms of GERD such as heartburn, regurgitation of acid, and nausea. The medication helps allow the esophagus to heal, and prevent further damage to the esophagus. Rabeprazole is also used to treat conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. In addition, rabeprazole is used to treat ulcers (sores in the lining of the stomach or intestine) and is used in combination with other medications to eliminate H. pylori, a type of bacteria that causes ulcers.
 
In the clinical trials for 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.
 
Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
 
Information about the availability of generic rabeprazole can be obtained from the manufacturers.
 
For more information:
 
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 
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