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

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

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.

“The approval of the first generic version of Aciphex delayed-release tablets may now offer patients access to this type of proton pump inhibitor which may have been restricted in the past due to its brand only status,” Formulary advisor Abimbola Farinde, PharmD, MS, who is also on the faculty at Columbia Southern University, Orange Beach, Ala. “Providers now have the option of prescribing this generic version to their patients and the affordability of this agent will increase patients' ability to take advantage of the drug's therapeutic benefits.”

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

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.

Rabeprazole, a proton-pump inhibitor, decreases the amount of acid made in the stomach, treating the symptoms of GERD such as heartburn, regurgitation of acid, and nausea. Rabeprazole helps allow the esophagus to heal, and prevent further damage to the esophagus. It 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.