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news.Both Impax and Mylan Laboratories have been granted separate FDA approvals to market generic versions of Bristol-Myers Squibb's Glucophage XR medication for the treatment of type 2 diabetes.
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The generic versions of the drug will now compete in a market place where, according to NDCHealth, US sales of Glucophage XR 750mg were approximately $23 million in the 12 months ended June 2005.
These approvals are the results of successful abbreviated new drug applications made by the companies to the FDA. Abbreviated applications expediate the regulatory process as they are not usually required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead they only have to demonstrate bioequivelence to the already approved brand version of the drug.