Forest Pharmaceuticals has agreed to pay more than $300m to settle charges that it improperly marketed two products.
The firm pleaded guilty to obstructing a US Food and Drug Administration (FDA) investigation and other misdemeanour charges.
Go deeper with GlobalData
The charges primarily relate to Forest’s marketing of Levothroid (levothyroxine sodium tablets, USP), an unapproved drug used for the treatment of hypothyroidism.
A 1997 Federal Register notice announced that these products are considered “new drugs” within the meaning of the Federal Food Drug and Cosmetic Act (FDCA) and forced manufacturers to obtain approved applications from the FDA by August 2000.
Because levothyroxine was considered a medically necessary product, the FDA permitted a gradual phase-out to cease no later than August 2003, but Forest increased its distribution and ignored a subsequent letter warning them to stop halt the drug’s manufacture and distribution.
Forest Pharmaceuticals is also charged with the off-label promotion of its Celexa antidepressant for paediatric use, when it had only been approved for the treatment of depression in adults.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData
