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GLUCOTROL (GLIPIZIDE) APPROVAL GIVES PFIZER NEW ORAL HYPOGLYCEMIC

Executive Summary

GLUCOTROL (GLIPIZIDE) APPROVAL GIVES PFIZER NEW ORAL HYPOGLYCEMIC just prior to the patent expiration of the firm's market-leading Diabinese (chlorpropamide). The approval, nearly eight years after the NDA was first filed, comes about four months before the Diabinese patent expires. At least one firm, Bolar, has already received ANDA approval for chlorpropamide. In 1983, Diabinese ranked tenth in terms of retail (at acquisition cost) Rx sales volume among Rx drugs marketed in the U.S. Glucotrol joins glyburide (Hoechst-Roussel's Dia beta eta and Upjohn's Micronase) among the second generation oral hypoglycemic approved in the U.S. Both drugs had long approval times due to the debate over the University Group Diabetes Program study ("The Pink Sheet" May 7, T&G-1). FDA approved Glucotrol on May 8. Like glyburide, Glucotrol was approved as an adjunct to diet in controlling hyperglycemia. The FDA approved labeling states that Glucotrol "is indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with non-insulin dependent diabetes mellitus (NIDDM type II), formerly known as maturity onset diabetes, after an adequate trial of dietary therapy has proved unsatisfactory." Unlike glyburide, however, a statement in the clinical pharmacology section asserts: "Some patients fail to respond initially, or gradually lose their responsiveness to sulfonylurea drugs, including Glucotrol. Alternatively, Glucotrol may be effective in some patients who have not responded or have ceased to respond to other sulfonylureas." In a press release announcing the approval, the company asserts that the drug "has been shown to be effective in a majority of patients previously failing on diet alone, and in 50% of those patients who previously failed on other oral agents. Research has shown that the therapeutic benefits of Glucotrol have not diminished in patients receiving the drug for up to six years." Glucotrol will be marketed by Pfizer's Roerig Div.
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