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U.S. Department of Health and Human Services

Safety

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Avandia (rosiglitazone maleate)

Audience: Endocrinologists, pharmacists, patients

[Posted 02/26/2008] FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate). The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. The Medication Guide and current Prescribing Information for Avandia are provided below.

[February, 2008 - Medication Guide - GlaxoSmithKline]
[January, 2008 - Prescribing Information - GlaxoSmithKline]

List of Currently Approved Medication Guides