FDA approves first generic versions of Aciphex delayed-release tablets to treat GERD
FRIDAY, Nov. 8 (HealthDay News) -- The first generic versions of the gastroesophageal reflux disease drug Aciphex (rabeprazole sodium) have been approved by the U.S. Food and Drug Administration for people aged 12 and older, the agency said Friday.
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 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.
Information about the availability of generic rabeprazole can be obtained from the manufacturers, according to the FDA.
More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374329.htm )