PITTSBURGH _ Mylan Inc. Friday said it has agreed to a $465 million settlement with the U.S. Department of Justice and other government agencies over questions arising from the company's classification of its EpiPen auto-injector as a non-innovator drug for Medicaid programs.
Mylan was already under fire for the sharp increase in the life-saving EpiPen's price, going from about $100 for two to more than $600 since 2007.
Last month, U.S. senators asked the Justice Department to investigate whether the company, with operational headquarters in the Pittsburgh area, had been using the wrong classification for rebates from the government Medicaid program.
By classifying EpiPen as a more established "non-innovator" drug, Mylan paid a 13 percent rebate instead of a 23.1 percent rebate required of an "innovator" drug. Members of the Senate asked the Justice Department to investigate whether Mylan had knowingly misclassified EpiPens.
In a release, Mylan said Friday's settlement terms "do not provide for any finding of wrongdoing" on the company's part.
