The first patent for Avandaryl (rosiglitazone and glimepiride) expired in March 2012. However, there are no generic versions available at this time, which suggests that Avandaryl could still have an unexpired patent protecting it from generic competition. If your insurance does not cover Avandaryl, you may want to see if it covers Avandia and Amaryl (the brand names of the active ingredients) separately.
In September 2010, the U.S. Food and Drug Administration (FDA) announced that it was severely restricting the use of Avandaryl, due to the risk of "cardiovascular events" such as heart attacks and strokes. Only individuals who could not control their diabetes on other medications (or those who were already taking the medication and doing well) would be able to take Avandaryl.
However, in November 2013, the FDA announced that a careful analysis of the research suggests that there is not, in fact, any increased risk, compared to treatment with standard diabetes medications and that the use of this medication will no longer be restricted.
Avandaryl is manufactured by GlaxoSmithKline. It is currently under the protection of a patent that prevents any generic Avandaryl from being manufactured in the United States. Yet, if you search the Internet for "generic Avandaryl," you may find a number of companies selling it. The fact is that these medicines are fake, substandard, and potentially dangerous. There may be generic Avandaryl available from another country, but there is really no way of knowing if you are getting genuine Avandaryl or not. You should not buy any generic Avandaryl until there is an approved generic available.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Avandaryl [package insert]. Research Triangle Park, NC: GlaxoSmithKline;2011 February.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines (November 25, 2013). FDA Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm376389.htm. Accessed December 20, 2013.
Food and Drug Administration, Center for Drug Evaluation and Research. Avandia (rosiglitazone): REMS - risk of cardiovascular events (9/23/2010). FDA Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm. Accessed October 1, 2010.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed April 10, 2012.
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