The SEC accused the Canonsburg, Pa., pharmaceutical company of failing to disclose to investors a possible loss relating to a Department of Justice investigation regarding the best-selling product.
"Mylan believes at this time, taking all other matters into consideration, that this settlement is the right course of action for the company," the company said in a release on Friday. In settling the case, the company neither admitted nor denied wrongdoing.
The company in July disclosed that it had reached a settlement in principle with the SEC.
According to a release on Friday, the SEC says the charges are "for accounting and disclosure failures" relating to a DoJ probe into whether Mylan overcharged Medicaid by hundreds of millions of dollars for sales of the EpiPen, which is used to treat severe allergic reactions.
The SEC's complaint says Mylan classified EpiPen as a generic drug under the Medicaid Drug Rebate Program, "which resulted in Mylan paying much lower rebates to the government than if EpiPen had been classified as a 'branded' drug," the release says.
"As alleged in our complaint, investors were kept in the dark about Mylan's EpiPen misclassification and the potential loss Mylan faced as a result of the pending investigations into the misclassification," Antonia Chion, associate director in the SEC's enforcement division, said in a statement.
"It is critical that public companies accurately disclose material business risks and timely disclose and account for loss contingencies that can materially affect their bottom line."
In its statement on Friday, Mylan said the company "continues to be committed to the highest levels of integrity with respect to all aspects of its business operations, including its public filing disclosures and communications with investors."
Mylan shares were trading off 0.8% at $19.61.