Generic Version of Actos Approved for Market by the FDA

Generic Actos has been approved by the FDAOn Friday, August 17th, the FDA approved generic pioglitazone, which the highly controversial Actos is based on.

The drug company approved to manufacture the generic drug is Mylan Pharmaceuticals, based in Morgantown, West Virginia. Meanwhile, the FDA is being sued by Watson Pharmaceuticals for the rights to the generic version of Actos. In addition, Actos and its manufacturer Takeda Pharmaceuticals have come under heavy fire in the US and in Europe in the past two years. France and Germany both took Actos completely off the market last year, and the FDA in the United States issued the most serious warning against using Actos.

Actos is still prescribed in the US, but several recent studies link the drug to an increased risk of bladder cancer, especially after more than a year of use. However, Actos, and now its generic version, are meant to combat Type 2 diabetes when other options, such as changes in diet and exercise, as well as other drugs like metform. The FDA recommends that doctors carefully monitor patients on pioglitazone, and start with small doses, only increasing if necessary.

Mylan Pharmaceuticals will offer pioglitazone in 15 milligrams (mg), 30 mg, and 45 mg. The most common side effects of the generic drug in studies are cold-like symptoms, sinus infection, headache, sore throat, and muscle pain.

Meanwhile, more lawsuits are consistently filed against Takeda Pharmaceuticals, the manufacturers of Actos. Lawsuits allege that Takeda should have known, or, in some cases, willfully misled the public, about the harmful side effects of Actos, which include not only increased risk of bladder cancer, but heart disease, liver failure, and diabetic macular edema. The lawsuits are consolidated into one multidistrict litigation, MDL 2299, with the Hon. Rebecca Doherty presiding.

If you or a loved one have used Actos to treat your Type 2 diabetes for more than 2 years, and have since been diagnosed with bladder cancer, heart disease, liver failure, or macular edema, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC, are accepting cases nationwide, and can help you get the compensation you need to continue medical treatment and an appropriate quality of life. Contact us today for a free consultation. 803.252.4800.

About Pete Strom

Defending criminal charges including drug crimes, DUI, CDV, mail fraud, wire fraud, bank fraud, computer crimes, money laundering, and juvenile crimes, Pete also handles Federal and State investigations. Representing individuals in Civil Matters including Class Actions, Personal Injury, Qui Tam Actions, Defective Products, Nursing Home Neglect, and Professional Licensing Defense cases. Joseph Preston “Pete” Strom, Jr., the managing partner at Strom Law Firm, L.L.C., has been fighting for justice since 1984.


  1. […] generic version of Actos – pioglitazone – has been approved by the FDA for market in the United States. The FDA’s approval comes despite more and more lawsuits against Takeda Pharmaceuticals, […]

  2. […] this month, despite numerous lawsuits against Takeda Pharmaceuticals Actos, the FDA approved pioglitazone – the generic name for Actos – for market in the United States. Now, watchdog group Consumer […]

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