Ranbaxy gets US FDA nod for glycopyrrolate tabs to treat peptic ulcer

Ranbaxy Laboratories Limited (RLL), has received approval from the US Food and Drug Administration (US FDA) to manufacture and market glycopyrrolate tablets USP, 1 mg and 2 mg. The Office of Generic Drugs, US FDA, 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. glycopyrrolate tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.