AstraZeneca (AZN) Sues FDA Over SEROQUEL Citizen Petitions Denial
Tweet Send to a Friend
Up)
AstraZeneca (NYSE: AZN) has filed a lawsuit against the US Food and Drug Administration (FDA) in the US District Court for the District of Columbia to overturn the FDA’s denial on March 7, 2012 of the company’s Citizen Petitions with regard to SEROQUEL (quetiapine fumarate) tablets and SEROQUEL XR® (quetiapine fumarate) extended release tablets.
In the Citizen Petitions, AstraZeneca raised important issues regarding labeling requirements for generic copies of innovative medicines, as well as data exclusivity rights granted to innovative companies that conduct new clinical trials.
AstraZeneca seeks an injunction barring the FDA from granting final marketing approval of generic quetiapine until December 2, 2012 when regulatory exclusivity expires on important clinical trial data, or, alternatively, at least until a federal court has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
In the Citizen Petitions, AstraZeneca raised important issues regarding labeling requirements for generic copies of innovative medicines, as well as data exclusivity rights granted to innovative companies that conduct new clinical trials.
AstraZeneca seeks an injunction barring the FDA from granting final marketing approval of generic quetiapine until December 2, 2012 when regulatory exclusivity expires on important clinical trial data, or, alternatively, at least until a federal court has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- Novo Nordisk (NVO) Reports Positive Results from Paradigm 2
- U.S. SEC Appoints Lona Nallengara as Chief of Staff; Keith Higgins as Corp. Finance Director
- St. Jude (STJ) Receives CE Mark for LUMIEN OPTIS PCI System
Create E-mail Alert Related Categories
Corporate News, FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
