FDA Approves First Generic Versions Of Aciphex Delayed-Release Tablets

The Food and Drug Administration Nov. 8 approved the first generic versions of Eisai Inc.'s Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).

Eisai Inc. also announced Nov. 8 that it has launched a different version of the drug, Aciphex Sprinkle (rabeprazole sodium) delayed-release 5 mg and 10 mg capsules, which is approved by the FDA for the treatment of GERD in children.

The FDA approved generic versions of Aciphex made by Dr. Reddy’s Laboratories Ltd., Kremers Urban Pharmaceuticals Inc., Lupin Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Teva Pharmaceuticals ...