Generic Aciphex approved to treat GERD

FDA Approves Generic Aciphex to Treat GERD
FDA Approves Generic Aciphex to Treat GERD

HealthDay News -- The FDA has approved the first generic versions of the gastroesophageal reflux disease (GERD) drug Aciphex (rabeprazole sodium) for people aged 12 and older, the agency has announced.

“This medication is widely used by people who have [GERD], so it is important to have access to affordable treatment options,” Kathleen Uhl, MD, acting director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, said in a press release.

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 prevents further damage to the esophagus.

License to produce generic rabeprazole was granted to Dr. Reddy's Laboratories, Kremers Urban Pharmaceuticals, Lupin Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals and Torrent Pharmaceuticals, the FDA said in a press release.

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

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 and is used in combination with other medications to eliminate Helicobacter pylori, a type of bacteria that causes ulcers.

 
Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs, and drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs, the agency said.
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