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Priority review designations

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

AstraZeneca's NDA for Entocort budesonide modified-release capsules is granted priority review. The application was submitted Jan. 24 for treatment of active, mild to moderate Crohn's disease. Three biologics also were recently given priority review status: Lilly's Zovant (drotrecogin alfa) for treatment of sepsis with associated acute organ dysfunction, submitted in late January; Novartis' Glivec (imatinab), submitted Feb. 27 for use in treatment of chronic myeloid leukemia in the blast crisis, accelerated or chronic phases of the disease after failure of interferon alpha; and Schering-Plough's sBLA for combination use of PEG-Intron (peginterferon alfa-2b) with Rebetrol (ribivarin) for treatment of chronic hepatitis C in adults who were not previously treated with interferon alpha who have compensated liver diseas
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