Eon Labs Inc. has agreed to pay the United States $3.5 million to resolve False Claims Act allegations relating to the company’s drug Nitroglycerin Sustained Release (SR) capsules, the United States Department of Justice (DOJ) announced Feb. 22, 2010. Eon Labs is a subsidiary of Sandoz Inc., which is in turn a subsidiary of Novartis AG.
In April 1999, the Food & Drug Administration (FDA) determined that the unapproved drug Nitroglycerin SR lacked substantial evidence of effectiveness and published a notice proposing to withdraw approval of the product. The qui tam lawsuit alleged that, after the FDA notice, Nitroglycerin SR no longer was legally eligible for reimbursement by government health care programs such as Medicaid.
The lawsuit alleged that Eon submitted false quarterly reports to the government that misrepresented Nitroglycerin SR’s regulatory status as a Covered Outpatient Drug under the Medicaid program.
The settlement resolves allegations against Eon in a multi-defendant whistleblower action, which remains sealed in part.
For the full release, go to: http://www.justice.gov/opa/pr/2010/February/10-civ-171.html.