Despite ongoing litigation and claims that prescription drug Actos is linked to several side effects including cancer, Indian company Torrent Pharmaceuticals Ltd. has just received regulatory approval from the FDA to produce a generic version of Actos and Actoplus Met. In addition to Torrent, another pharmaceutical firm, Aurobindo Pharma Ltd. has also received similar approval from the FDA to manufacture and market generic versions of Actos as well.

Meanwhile firms across the US continue to take up investigations into Actos and its links to bladder cancer. Lawsuits on behalf of individuals treated with the type-2 diabetes drug continue to be filed and the multidistrict litigation (MDL) is pressing forward. The MDL currently underway in U.S. District Court, Western District of Louisiana is scheduled for a February 21, 2013 status conference in preparation for next year’s trial.

Many patients treated with Actos for their type-2 diabetes are still coming forward claiming the drug caused bladder cancer, while scores of others may still be at risk. Back in June 2011 when a study of the drug revealed the increased risk of bladder cancer for those that took Actos, the FDA ordered Takeda Pharmaceuticals, the maker of Actos, to include further warnings on its drug label. Since then, numerous studies have surfaced in throughout the US as well as other countries that substantiate the claims made by many of the claimants. It seems no further regulations have been implemented; instead the FDA has given approval for the manufacturing of the generic drug in another country.

It is estimated that as many as 10,000 Actos bladder cancer lawsuits await Takeda. The first trial is scheduled to begin in November of 2014 and the next in July 2015.