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news.Synovics Pharmaceuticals has received its first FDA approval for a generic drug, namely an oral controlled-release version of the diabetes drug metformin.
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The FDA has approved Synovics’ abbreviated new drug application (ANDA) for a generic version of metformin extended release (XR) tablets 500mg. Bristol-Myers Squibb markets the therapeutically equivalent listed drug, Glucophage XR 500mg.
“This is a very significant milestone for our company,” said Dr Ronald Lane, Synovics chairman and CEO. “We also plan to seek approval of a generic oral controlled-release (OCR) 750mg dose of metformin, as well as develop a generic immediate release formulation that addresses a market opportunity in excess of $1 billion.”
Metformin generic XR formulations are currently sold in the US, and thus Synovics does not expect legal challenges to its product launch.
The company plans to launch a direct sales program for its generic metformin XR tablets 500mg in the first quarter of 2007.