August 20, 2012 — The U.S. Food and Drug Administration (FDA) has announced that Mylan Pharmaceuticals has gained approval for generic Actos (pioglitazone) in 15-mg, 30-mg, and 45-mg doses. The drug is used along with diet and exercise to help people with Type-2 diabetes control their blood-sugar levels. The announcement comes after years of research linking Actos to bladder cancer.
The generic version of Actos will carry a Black Box warning that it can cause or worsen heart failure, especially in certain patient populations. The label will also warn that using Actos for more than one year may increase a patient’s risk of bladder cancer.
Several studies have linked Actos to an increased risk of bladder cancer. Health authorities in France and Germany have banned sales of Actos. The FDA published a Safety Communication in 2011 after a study found that using Actos for more than one year increased the risk of bladder cancer by 40%. Other studies have also linked Actos to an increased risk of bladder cancer, including one recent study that suggests the increased risk of bladder cancer may be a class effect of all thiazolidinediones (TZDs), which also includes Avandia.
Watson Pharmaceuticals has recently sued the FDA over the generic approval. Watson wants the FDA to grant it shared exclusive rights to market the generic version of Actos. This would keep most other generic drugs off the market for the next 180 days. Watson claims that they followed all the correct procedures, but the FDA granted Mylan 180 days of exclusive marketing for the drug.
Actos is manufactured by the Japanese drug company Takeda Pharmaceuticals. Takeda and Watson entered into an agreement in which Takeda granted Watson rights to produce a generic version of Actos on August 17, 2012. The patent technically does not expire until 2016. Generic drug companies are eager to produce generic Actos — the drug had total U.S. sales of $2.7 billion for the year ending on May 31, 2012.
Hundreds of Actos lawsuits are currently pending in courtrooms around the nation. There is a Multidistrict Litigation (MDL) pending in Louisiana, and the first bellwether trials are set for late 2014 and early 2015. Those trials will set precedent for deciding hundreds of other lawsuits. Most of the plaintiffs allege that Takeda failed to warn about the risk of bladder cancer.
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