FDA MedWatch - Avandia (rosiglitazone maleate): new Medication Guide issued

ROCKVILLE, Md., Feb. 26, 2008-The 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.

See the MedWatch 2008 safety summary, including links to the Medication Guide and the current Prescribing Information for Avandia, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avandia

Posted: February 2008

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