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COLMED's MEGESTROL ACETATE IS FIRST GENERIC VERSION OF BRISTOL-MYERS' MEGACE

Executive Summary

COLMED's MEGESTROL ACETATE IS FIRST GENERIC VERSION OF BRISTOL-MYERS' MEGACE to be approved by FDA. Colmed's ANDA application for megestrol acetate 20 and 40 mg tablets was approved Oct. 2. Colmed has already begun shipments of generic megestrol acetate tablets. The product will be marketed through Colmed's parent company Pharmaceutical Basics, Inc. Colmed estimates the market for megestrol acetate at approximately $25 mil. The drug is indicated for the palliative treatment of breast and endometrial cancer. American Home Products' generic subsidiary, Quantum, submitted an ANDA suitability petition on March 20 for megestrol acetate 10 and 20 mg tablets. In a May 21 letter to FDA responding to the Quantum petition, Bristol-Myers suggested that Quantum be required to perform multiple-dose bioequivalence studies comparing their 10 and 20 mg products to Megace 20 and 40 mg tablets ("The Pink Sheet" June 8, T&G-9). Bristol-Myers asserted that Quantum's single-dose, in vivo study was inadequate to determine steady-state levels. Bristol-Myers also noted that the time to peak plasma level may vary between the products and may affect therapeutic equivalence.
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