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Drug Development

U.S. FDA grants approval for extended-release Glumetza

Published in Obesity and Diabetes Week, July 4th, 2005

Biovail Corporation (BVF) and Depomed, Inc., (DEPO) announced that they have received an approval letter from the United States Food and Drug Administration (FDA) for Glumetza, a once-daily, extended-release formulation of metformin hydrochloride (HCl) for the treatment of Type II diabetes.

In early April, Biovail and Depomed submitted a complete response to the approvable letter received in February. The response addressed the finalization of one manufacturing specification.

Glumetza may offer potential advantages such as less frequent dosing and proven effectiveness in combination with other diabetes drugs. Glumetza also offers excellent...

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