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Bristol effort to overturn Upsher-Smith cholestyramine ANDA approval denied by D.C. federal court.

Executive Summary

UPSHER CHOLESTYRAMINE ANDA: BRISTOL DENIED IN REQUEST TO SET ASIDE approval granted by FDA Feb. 22 for Upsher-Smith's Prevalite, the first generic of Bristol-Myers Squibb's Questran, in D.C. federal court on March 25. Bristol filed a motion for preliminary injunctive relief, requesting that the court set aside FDA's approval of Prevalite because the determination that the drug is bioequivalent to Questran was based solely on in vitro studies. Washington, D.C. federal court Judge Ricardo Urbina denied Bristol's preliminary request.
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PS027940

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