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The Glaxo case underscores how aggressive the Justice Department has become in going after similar cases. In a May settlement, Abbott Laboratories pleaded guilty and agreed to pay the government a $700 million criminal fine and forfeiture for promoting Depakote, approved for bipolar disorder and epilepsy, for use in patients with dementia and autism. That was on top of civil settlements with numerous states and the federal government totaling $800 million.

Prior to the Glaxo settlement, the record-setting case involved Pfizer Inc., the world’s biggest drugmaker. It paid the government $2.3 billion in 2009 in criminal and civil fines for improperly marketing 13 different drugs, including erectile-dysfunction drug Viagra and cholesterol fighter Lipitor, the top-selling drug in the world for years. Pfizer was accused of encouraging doctors to prescribe its drugs with free golf, massages and junkets to posh resorts.

“For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business,” said Acting Assistant Attorney General Stuart F. Delery, head of Justice’s civil division. “Today’s resolution seeks not only to punish wrongdoing and recover taxpayer dollars, but to ensure GSK’s future compliance with the law.”

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Associated Press writer Jesse J. Holland in Washington contributed to this story.

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Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma