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MORRISTOWN, N.J. — Actavis Group has been cleared to market pantoprazole sodium delayed-release tablets in the United States.
The generic pharmaceuticals company said this week that it received approval from the Food and Drug Administration to offer pantoprazole sodium delayed-release tablets in 20-mg and 40-mg strengths, the generic equivalent of Pfizer’s Protonix.
Plans call for distribution of the new generic medication, indicated for the treatment of gastroesophageal reflux disease (GERD), to begin soon, according to Actavis.
Pantoprazole sodium delayed-release tablets (20 mg and 40 mg) had U.S. sales of about $1.6 billion in 2010, according to IMS Health figures reported by Actavis.
Generic versions of Protonix also were introduced in late January by Dr. Reddy’s Laboratories and Mylan Inc.’s Matrix Laboratories.
