FDA Approves Generic Versions of Actos

FRIDAY Aug. 17, 2012 -- The first generic versions of pioglitazone (Actos) have been approved by the U.S. Food and Drug Administration to help adults with type 2 diabetes control blood glucose levels.

License to produce the generic versions in 15 milligrams (mg), 30 mg and 45 mg strengths was granted to Mylan Pharmaceuticals, based in Morgantown, W. Va, the agency said Friday in a news release.

As with the brand name drug, generic versions will contain a label warning that the drug could cause or worsen heart failure in certain people. And there may be an increased risk of bladder cancer in people who take the drug for more than a year, the FDA said.

The most common side effects associated with the drug include cold-like symptoms, headache, sinus infection, muscle pain and sore throat.

Generic versions of FDA-approved drugs are chemically equivalent in strength and quality to their brand-name counterparts, the agency said. Actos is produced by Takeda Pharmaceutical Co.

More information

To learn more about pioglitazone, visit Medline Plus.

Posted: August 2012


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