Citizen Petitions for Warning on AstraZeneca Label Denied

The FDA has turned down a request from individuals requesting the agency withhold approval of a label that omits hyperglycemia warning language.

AstraZeneca announced that on March 7, the Food and Drug Administration (FDA) denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for Seroquel (quetiapine fumarate) tablets and Seroquel XR (quetiapine fumarate) extended-release tablets.

AstraZeneca said it is evaluating the FDA's decision and reasoning.

On September 9, 2011 AstraZeneca filed a Citizen Petition with the FDA for each of Seroquel and Seroquel XR, requesting the FDA withhold finally approving any generic quetiapine product that omits from its labeling certain hyperglycemia and suicidality warning language that FDA required AstraZeneca to include in the labeling for Seroquel and Seroquel XR. Data associated with the hyperglycemia warning language at issue is protected by marketing exclusivity periods expiring as late as December 2.

The patent covering the active ingredient in Seroquel and Seroquel XR expired in September 2011, with pediatric exclusivity expiring March 26. Seroquel XR is covered by a formulation patent that expires in May 2017, with pediatric exclusivity expiring in November 2017. In 2011 AstraZeneca granted both Handa and Accord a license to enter the U.S. market with generic Seroquel XR on November 1, 2016, or earlier under certain circumstances.

AstraZeneca is a global biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease.

Source: AstraZeneca
 

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