AstraZeneca files lawsuit against FDA regarding quetiapine

Wednesday, March 14, 2012 09:56 AM

AstraZeneca has filed a lawsuit against the FDA in district court to overturn the FDA’s denial on March 7, 2012, of citizen petitions filed by AstraZeneca with regard to Seroquel tablets and Seroquel XR extended release tablets (quetiapine fumarate).

In the citizen petitions, AstraZeneca requested the FDA withhold finally approving any generic quetiapine product that omits from its labeling certain hyperglycaemia and suicidal warning language that the FDA required AstraZeneca to include in the labeling for its own Seroquel products. Data associated with the hyperglycaemia warning language at issue is protected by marketing exclusivity periods expiring as late as December 2, 2012. AstraZeneca also raised issues regarding 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.

AstraZeneca said it will “vigorously defend its legal rights.”

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

Covance, Frenova form partnership to share patient databases, find effective treatments for renal disease

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs