Synovics gets FDA approval for generic version of Metformin

By Elaine Rigoli

Tampa, Fla., July 31 - The Food and Drug Administration has approved Synovics Pharmaceuticals, Inc.'s abbreviated New Drug Application for a generic version of metformin extended-release tablets 500 mg.

Bristol-Myers Squibb Co. markets the therapeutically equivalent listed drug, Glucophage XR extended-release tablets 500 mg for type 2 diabetes management.

The U.S. market for extended-release metformin is estimated to be more than $150 million annually, the company said in a news release.

Synovics said it plans to launch a direct sales program for its generic metformin tablets in the first quarter of calendar 2007.

Metformin generic formulations are sold in the United States, but Synovics said it does not expect legal challenges to its product launch.

Synovics is a specialty pharmaceutical company located in Phoenix.

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