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Type 2 Diabetes

Glycemic control monotherapy granted tentative approval by FDA

Published in Obesity and Diabetes Week, December 1st, 2003

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

Total market sales for all forms of Metformin were $1.6 billion with sales of $452.4 million for the Metformin Extended-release formulation (IMS - MAT: June 2003).

Metformin Hydrochloride Extended-release Tablets (Glucophage XR) as monotherapy is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type...

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