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9/22/2003

Metformin Solution Approved by FDA

Cheryl A. Thompson

The Food and Drug Administration recently approved the marketing of Riomet, the first oral liquid formulation containing 100 mg of metformin hydrochloride per milliliter.

A spokesman for Ranbaxy Pharmaceuticals Inc. said the company expects to have Riomet in pharmacies by late January 2004.

As with other immediate-release formulations of metformin, Ranbaxy's product is indicated for use as single-drug therapy to better control the blood glucose concentration in patients with type 2 diabetes mellitus who are following appropriate diet and exercise regimens. Metformin must not be used by patients with renal disease or dysfunction, congestive heart failure requiring drug treatment, or a metabolism-related increase in the acidity of body fluids, such as diabetic ketoacidosis.

The Ranbaxy spokesman said the metformin solution is cherry flavored and artificially sweetened and will be packaged in 4- and 16-oz containers.