Generic versions of Aciphex approved by FDA to treat GERD

The FDA has approved the first generic versions of Aciphex delayed-release tablets to treat gastroesophageal reflux disease.

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

The most common adverse reactions in clinical trials for Aciphex (rabeprazole sodium, Eisai) in adults were sore throat, flatulence, infection and constipation. Adverse reactions most frequently reported by adolescents were abdominal pain, diarrhea and headache.

Rabeprazole is a proton-pump inhibitor that treats heartburn, regurgitation of acid and nausea by decreasing the amount of acid produced in the stomach, according to the release. It also treats Zollinger-Ellison syndrome, a condition in which the stomach produces too much acid. In addition, rabeprazole is used in combination with other medications to eliminate Helicobacter pylori bacteria that cause ulcers.

Six companies were granted FDA approval to market generic rabeprazole, the release said.