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FDA Approval Sought For Once-Daily Glucophage For Type 2 Diabetes PRINCETON, NJ -- November 17, 1999 -- Bristol-Myers Squibb Company announced that it has submitted a regulatory application to the U.S. Food and Drug Administration (FDA) to gain marketing approval for Glucophage(R) XR (metformin hydrochloride) Extended Release Tablets, a once-daily version of the number one prescribed oral antidiabetic drug in theUnited States. Glucophage XR is designed to offer people with type 2 diabetes a more convenient option to better manage their condition. "As a leader in the oral diabetes market, Bristol-Myers Squibb is dedicated to developing products that extend and enhance the lives of patients with type 2 diabetes," said Richard J. Lane, president, U.S. Medicines and Global Marketing, Bristol-Myers Squibb. "It is estimated that 60 percent of patients with type 2 diabetes who receive oral therapy are currently required to take doses of multiple pills several times a day in order to manage their condition. Therefore, it is our hope that Glucophage XR will help these patients better control their blood sugar by making it easier to comply with their daily treatment regimen." The company's New Drug Application (NDA) filing for Glucophage XR (metformin hydrochloride) Extended Release Tablets is based on data from approximately 1200 patients enrolled in three clinical studies. The results of the studies demonstrate that Glucophage XR has efficacy that is equivalent to the currently marketed Glucophage product. The data also demonstrate that Glucophage XR has a favorable safety and tolerability profile that is equivalent to the currently marketed Glucophage product. Based on these data, the company has asked the FDA to approve Glucophage XR for use as initial therapy for patients with type 2 diabetes who are unable to control their condition with diet and exercise alone and also in combination with other oral agents (sulfonylureas) and with insulin as type 2 diabetes progresses. Related Link: Glucophage(R) XR (metformin hydrochloride) and Bristol-Myers Squibb Company. E-mail this page to a friend or colleague! To print, use this version