MENLO PARK, Calif.--(BUSINESS WIRE)--Jan 2, 2008 - Depomed, Inc. (NASDAQ:DEPO) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the 1000 mg strength tablets of Glumetza(TM) (metformin hydrochloride extended release tablets).
"This approval is good news for patients with type 2 diabetes who are on metformin therapy and prefer to take fewer tablets per day," stated Carl A. Pelzel, president and chief executive officer of Depomed. "The American Diabetes Association guidelines recommend that metformin therapy be titrated to its maximally effective dose, generally regarded as 2000 mg/day as tolerated. We believe this 1000 mg dosage form is a great addition to the Glumetza franchise, as we now have two ways for patients to achieve 24-hour glycemic control: the original Glumetza 500 mg tablets, which start out as small, easy-to-swallow tablets that expand once in the stomach, and the new 1000 mg tablets, which require fewer tablets to hit the target dose. We are working very closely with our commercial supplier, Biovail, to make these tablets commercially available in the United States in the near future."
Depomed acquired exclusive United States rights to the 1000 mg formulation of Glumetza in December 2005 from Biovail, and has a supply agreement with Biovail related to the formulation. Biovail developed the new formulation with its Smartcoat(TM) AQ technology.
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