Par Pleads Guilty in Off-Label Case, Will Pay $45 Million

Par Pharmaceutical Cos., the generic-drug maker, pleaded guilty to marketing its AIDS drug Megace ES illegally and agreed to pay $45 million to resolve criminal and civil investigations.

In entering the plea today in federal court in Newark, New Jersey, Chief Executive Officer Paul Campanelli admitted Par sold Megace ES for uses not approved by the U.S. Food and Drug Administration. While the FDA approved the drug for treatment of anorexia and unexplained weight loss in AIDS patients, Par actively promoted it for so-called off-label uses, he said.