Metformin Solution Approved by FDA
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.