February 26, 2008
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. A list of currently approved Medication Guides are available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm. The Medication Guide and current Prescribing Information for Avandia are provided below.
Most important information about Avandia
More information about AVANDIA (Rosiglitazone):
AVANDIA (Rosiglitazone): What You Should Know
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Avandia Reduces Risk of Progresson from Pre-Diabetes to Type 2 Diabetes by 62 percent
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Data Affirms Avandia (Rosiglitazone maleate) Cardiovascular Safety Profile
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Tags: Avandia, FDA Alert, Type 2 Diabetes