AstraZeneca Pushes DC Circ. To Stretch Seroquel Exclusivity

Law360, Washington (March 21, 2013, 5:54 PM EDT) -- AstraZeneca PLC told a D.C. Circuit panel Thursday that the U.S. Food and Drug Administration inappropriately refused to extend its exclusivity rights for the antipsychotic Seroquel despite new safety warnings and claimed the decision could discourage others from conducting additional safety tests on approved drugs.

According to the drugmaker, the FDA should have given the company three years of additional Seroquel exclusivity after it submitted new hyperglycemia warnings as part of a supplemental new drug application. The supplemental NDA also included two new pediatric uses for...
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