Par Pharma agrees $45 million settlement over off-label Megace ES promotion

US generic drugmaker Par Pharmaceutical NYSE: PRX) pleaded guilty in federal court yesterday (March 6) and agreed to pay $45 million to resolve its criminal and civil liability in the company’s promotion of its prescription drug Megace (megestrol acetate) ES for uses not approved as safe and effective by the Food and Drug Administration and not covered by federal health care programs, the Justice Department announced.

The FDA approved Megace ES (then a product of US drug major Bristol-Myers Squibb) in July 2005 for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome.

Result of whistleblower case