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Generic Version of Glucophage Approved by FDA
August 21, 2008
PITTSBURGH, Sept. 14 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE:MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Metformin Hydrochloride Extended-release Tablets, 500 mg and 750 mg. Metformin HCl ER Tablets, which are the generic version of Bristol-Myers Squibb's Glucophage(R) XR Tablets, 500 mg and 750 mg, had U.S. sales of approximately $173 million, for the 12-month period ending June 30, 2005, according to IMS.
This product will be available soon.
Source: Mylan Laboratories Inc.
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