Ranbaxy Laboratories announced that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Glycopyrrolate Tablets USP, 1 mg and 2 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Robinul® 1 mg and Robinul® Forte Tablets, 2 mg, respectively, of Sciele Pharma, Inc. The total annual market sales for Glycopyrrolate Tablets were $26 million (IMS - MAT: June 2009), according to the company. Glycopyrrolate Tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.
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