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Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Merck’s Januvia becomes the first DPP-4 inhibitor to reach the market. FDA clears Novartis’ nucleoside analog Tyzeka (telbivudine) for treatment of adults with chronic hepatitis B; the new molecular entity will be priced at a premium to GSK’s Epivir HBV (lamivudine). AstraZeneca’s Seroquel (quetiapine) gains an indication for treatment of depressive episodes associated with bipolar disorder. GlaxoSmithKline’s extended-release heart failure therapy Coreg CR (carvedilol) gains approval

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