There’s a New Metformin in Town!

FDA Clears New Generic Versions of Popular Type 2 Drug

| Mar 1, 2002

In late January, the floodgates opened as IVAX Corporation, Alpharma, Inc., Watson Pharmaceuticals, Inc., Andrx Corporation, and TevaPharmaceutical Industries announced that they were among the 11 companies who had received approval from the U.S. Food and Drug Administration to sell their generic versions of metformin, a popular oral medication used by people with type 2 diabetes.

The flurry of approvals is expected to cut into U.S. sales of Bristol-Myers Squibb's type 2 drug Glucophage. Until now, Bristol-Myers Squibb had held patent exclusivity on metformin, which generated annual sales of approximately $2 billion for the company.

On January 24, Watson Pharmaceuticals of Corona, California, announced it had received FDA approval for its metformin product. The next day, Miami-based IVAX announced approval of its plans to sell its metformin hydrochloride tablets in 500 mg, 625 mg, 750 mg, 850 mg and 1000 mg strengths. Alpharma of Fort Lee, New Jersey, and Andrx of Fort Lauderdale, Florida, also received FDA approval to manufacture and market metformin in 500 mg, 850 mg, and 1000 mg dosages.

IVAX told Diabetes Health that its generic metformin product will be immediately available at drugstores throughout the United States. The other companies could not immediately be reached for comment on when their products would be available.

Last year, Bristol-Meyers Squibb tried to thwart the FDA approval of generic versions of metformin, arguing that the FDA could not approve any generic versions because those versions would not be allowed to include labeling regarding the appropriate doses for children.

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Categories: Diabetes, Diabetes, Food, Metformin, Type 2 Issues, Type 2 Medications

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