AstraZeneca Loses Bid To Stretch Seroquel Exclusivity

Law360, New York (July 6, 2012, 1:46 PM EDT) -- A Washington federal judge has rejected AstraZeneca PLC's bid to overturn the U.S. Food and Drug Administration's approval of generic versions of its antipsychotic Seroquel on grounds that they violate the drugmaker's exclusivity rights, according to an opinion unsealed Thursday.

AstraZeneca, whose patent for Seroquel expired in March, contends that safety data it provided so the FDA would approve two additional pediatric uses of Seroquel forced it to relabel packaging so it contained a warning about hyperglycemia, or high blood sugar, which entitles AstraZeneca to exclusivity...
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