HYDERABAD, India — Dr. Reddy’s Laboratories has rolled out pantoprazole sodium delayed-released tablets, an antacid medication.
The company said Thursday that it’s launching the product, a bioequivalent generic version of Wyeth’s Protonix tablets in the U.S. market, in 20-mg and 40-mg strengths, with both dosages available in 90-count bottles.
Dr. Reddy’s abbreviated new drug application (ANDA) for the medication was approved by the Food and Drug Administration this week.
A proton-pump inhibitor, pantoprazole is used to treat gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus. It is also used to treat conditions in which the stomach produces too much acid.
Pantoprazole sodium delayed-released tablets had total U.S. sales of about $1.8 billion for the 12 months ended September 30, 2010, according to IMS Health figures cited by Dr. Reddy’s.