Parallel civil and criminal cases against Par Pharmaceuticals Company Inc. came to a close today as the company entered a guilty plea and agreed to a civil settlement worth tens of millions of dollars. Par admitted to misbranding its drug Megace ES, which was approved by the FDA for the treatment of AIDS-related weight loss, by promoting it for off-label uses like treating weight loss by the elderly.

Par’s total financial liability of $45 million includes an $18 million criminal fine and $4.5 million forfeiture, as well as $22.5 million to settle federal and state False Claims Act allegations. The company will also enter a five-year corporate integrity agreement involving extensive monitoring by internal and external reviewers.

The False Claims Act allegations against Par originated as three separate qui tam lawsuits brought by drug-industry whistleblowers. Two of those whistleblowers will share $4.4 million of today’s settlement.

Read the entire press release, “Par Pharmaceuticals Pleads Guilty and Agrees to Pay $45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing”