Type 2 Diabetes

Pharmaceutical company receives approval to market metformin hydrochloride

Published in Obesity and Diabetes Week, July 19th, 2004

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received final approval from the U.S. Food and Drug Administration to market Metformin Hydrochloride Extended-release Tablets, 500 mg.

The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Glucophage XR Tablets of Bristol Myers Squibb Company.

Total market sales for the Metformin Extended-release formulation are $363 million. The approval was granted after Barr Laboratories, Inc., a...

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Source: Obesity and Diabetes Week (2004-07-19)

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