PITTSBURGH — Matrix Laboratories Ltd. is shipping pantoprazole sodium delayed-release tablets, a medication for gastroesophageal reflux disease (GERD).
Parent company Mylan Inc. said Monday that Matrix received approval from the Food and Drug Administration for its abbreviated new drug application (ANDA) for pantoprazole sodium delayed-release tablets in 20-mg and 40-mg dosages.
The product is the generic version of Wyeth’s Protonix DR Tablets, indicated for the treatment of irritation of the esophagus caused by GERD, according to Mylan.
Pantoprazole sodium DR tablets had U.S. sales of approximately $1.7 billion for the 12 months ended Sept. 30, 2010, according to IMS Health figures reported by Mylan.