Is Generic Pioglitazone/Metformin as Good as Actoplus Met?
All generic medications must undergo certain tests to compare them to brand-name medications. The U.S. Food and Drug Administration (FDA) then looks at these tests to decide if the generics are equivalent to the brand-name medications and assigns a rating to each one.
An "AB" rating means that the FDA has determined that a generic medication is equivalent to a brand-name medication. All of the generic Actoplus Met versions currently available have an "AB" rating, meaning they should be equivalent to Actoplus Met. The authorized version from Teva has not been given a rating, and this makes sense, because it is the brand-name version that has been relabeled, so testing is unnecessary.
However, generic medications are allowed to have different inactive ingredients than the brand-name medication. This might include fillers, dyes, or other ingredients that may cause problems for people with allergies or sensitivities.
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 August 24, 2012.
Takeda Pharmaceutical Company Limited. Takeda completes settlements with all defendants in U.S. patent litigation involving ACTOS (pioglitazone HCI), ACTOplus met (pioglitazone HCl and metformin HCl) and Duetact (pioglitazone HCl and glimepiride) (12/22/2010). Takeda Web site. Available at: http://www.takeda.com/press/article_39045.html.
Mylan, Inc. Mylan announces first-to-file opportunity settlement agreements for Actoplus Met(R) and Actos(R) (3/16/2010). Mylan Web site. Available at: http://investor.mylan.com/releasedetail.cfm?ReleaseID=452248. Accessed April 1, 2010.
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