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In Brief: Medstone International

This article was originally published in The Gray Sheet

Executive Summary

Medstone International: Submits premarket approval application to FDA for use of its STS lithotripter device for treatment of gallstones in conjunction with Novartis' Actigall (ursodiol) gallstone dissolution medication, Medstone announces Sept. 4. The STS lithotripter, a shockwave generating device, is already approved for treatment of kidney stones. The combination therapy for gallstones is anticipated to speed clearance of the stones compared to drug therapy alone, the firm states. Medstone had suspended efforts to pursue FDA approval for biliary lithotripsy in 1990 due to the cost of FDA's requirement that PMAs include data comparing lithotripsy/ursodiol treatment to ursodiol alone; a Medstone PMA supplement for the indication was rejected by the agency in 1989 due to a lack of an Actigall-alone cohort. The new submission includes "an analysis of clinical trials for Actigall monotherapy," made possible under a cooperative agreement with Novartis predecessor Ciba-Geigy ("The Gray Sheet" Jan. 8, 1996, I&W-9)...
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