FDA issues final approval for manufacturing and marketing Ranbaxy's Glycopyrrolate tablets

Aug 25 2009

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL 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(R) 1 mg and Robinul(R) Forte Tablets, 2 mg, respectively, of Sciele Pharma, Inc. Total annual market sales for Glycopyrrolate Tablets were $26 million (IMS - MAT: June 2009). Glycopyrrolate Tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.

"We are pleased to receive this final approval for Glycopyrrolate Tablets. This product formulation will be launched in the October - December quarter to all classes of trade and further expands the number of affordable generic product formulations offered by RPI, that will be of benefit to patients, healthcare professionals and the U.S. healthcare system," according to Jim Meehan, Vice President of Sales and Distribution for RPI.