Litigation In Brief: Elan, Novartis Resolve Federal Marketing Investigations
Elan to settle DoJ Zonegran investigation: Elan announced on July 15 that it has reached an agreement in principle with the U.S. Attorney's Office in Massachusetts to pay $203.5 million to settle an investigation of its sales and marketing practices for the antiepileptic Zonegran (zonisamide). The company said it expects to plead guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act and to enter into a corporate integrity agreement with the HHS Office of Inspector General. Eisai acquired Zonegran from Elan in 2004. In 2006, the OIG served Eisai and Elan with subpoenas requesting their marketing materials for the drug (1"The Pink Sheet," Feb. 6, 2006)
Learn what's happening at the US FDA. On the go.
More from Archive
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
More from Pink Sheet
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.