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AstraZeneca Entocort EC clears FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Budesonide receives approval Oct. 2 for treatment of mild to moderate active Crohn's disease involving the ileum and/or ascending colon. AstraZeneca's NDA for Entocort EC, submitted in January, was assigned priority review and was deemed "approvable" July 24. Wholesale acquisition cost for the product is $1.81 per 3 mg capsule, or $5.43 for the recommended 9 mg daily dose
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