AstraZeneca Sues FDA Over Generic Seroquel Labels

Law360, New York (March 13, 2012, 1:12 PM EDT) -- AstraZeneca PLC has moved to overturn the U.S. Food and Drug Administration’s recent refusal to delay the launch of generic versions of the drugmaker’s blockbuster anti-psychotic drug Seroquel with labels that omit hyperglycemia warnings AstraZeneca was required to add, the company said Tuesday.

The U.K.-based company says its suit in Washington federal court seeks an injunction barring the FDA from granting final marketing approval for generic Seroquel until Dec. 2, when marketing exclusivity covering clinical data associated with the warnings expires, or at least until the...
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