Drug Development

U.S. FDA grants approval of metformin HCl extended-release tablets

Published in Medical Letter on the CDC and FDA, May 15th, 2005

Andrx Corporation (ADRX) announced that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for metformin hydrochloride extended-release tablets, 750mg.

Andrx has already commenced shipping this product.

Andrx's metformin HCl ER tablets, 750mg, are the AB-rated generic equivalent of Bristol-Myers Squibb's Glucophage XR Tablets, 750mg, a product indicated for the treatment of type 2 diabetes.

Andrx manufactures and commercializes generic versions of controlled-release, niche and immediate-release pharmaceutical products, including oral contraceptives.

This...

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Source: Medical Letter on the CDC and FDA (2005-05-15)

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