Depomed receives FDA approval for 1000mg dosage of diabetes drug

Glumetza (metformin hydrochloride extended release tablets) is indicated alone or in combination with a sulfonylurea or insulin as an adjunct to diet and exercise to improve glycemic control in adult patients (18 years and older) with type 2 diabetes.

Depomed acquired exclusive US rights to the 1000mg formulation of Glumetza in December 2005 from Biovail, and has a supply agreement with Biovail related to the formulation.

Carl Pelzel, president and CEO of Depomed, said: “We now have two ways for patients to achieve 24-hour glycemic control: the original Glumetza 500mg tablets, which start out as small, easy-to-swallow tablets that expand once in the stomach, and the new 1000mg tablets, which require fewer tablets to hit the target dose.”