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ASTRAZENECA PHARMACEUTICALS LP v. FOOD AND DRUG ADMINISTRATION et al
Case Number:
1:12-cv-00388
Court:
Nature of Suit:
Judge:
Firms
Companies
Government Agencies
Sectors & Industries:
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March 26, 2012
AstraZeneca Can't Get FDA Tip-Off On Generic Approvals
AstraZeneca PLC on Monday unsuccessfully tried to force the U.S. Food and Drug Administration to notify it before approving a generic form of its antipsychotic drug Seroquel, two days after losing its bid to delay the approval of Seroquel generics with labels that omit hyperglycemia warnings.
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March 23, 2012
AstraZeneca Can't Prevent FDA Approval Of Generic Seroquel
A Washington federal judge on Friday tossed AstraZeneca PLC's suit seeking to delay the launch of generic versions of its blockbuster anti-psychotic drug Seroquel with labels that omit hyperglycemia warnings AstraZeneca was required to add, finding the drugmaker's claim was not yet ripe for review.
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March 13, 2012
AstraZeneca Sues FDA Over Generic Seroquel Labels
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.