FDA approves first generic pioglitazone

August 17, 2012

Silver Spring, MD - The US Food and Drug Administration (FDA) today approved the first generic version of pioglitazone hydrochloride (Actos, Takeda Pharmaceuticals), which is used to improve blood glucose control in adults with type 2 diabetes[1]. The approval allows Mylan Pharmaceuticals to market the drug in 15-mg, 30-mg, and 45-mg tablets.

Pioglitazone comes with a boxed warning that states that the drug may cause or exacerbate heart failure, especially in certain patient populations. Consequently, clinicians should monitor patients when they start the drug or switch to a higher dosage.

Using pioglitazone for more than one year also may be linked to an increased risk of bladder cancer, according to the drug's label.


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